(405 days)
No
The summary describes mechanical hip replacement components and their compatibility analysis, with no mention of AI or ML.
Yes
Explanation: The device is indicated for various medical conditions of the hip, such as non-inflammatory degenerative joint disease, rheumatoid arthritis, avascular necrosis, and fractures, with the aim of restoring function and alleviating pain, which are therapeutic goals.
No
The provided text describes various hip system components (acetabular cups, femoral heads, stems, etc.) used for hip arthroplasty. These are implantable devices for treatment, not diagnostic purposes.
No
The device description explicitly states that the subject devices are comprised of physical hip products including acetabular cups, liners, bone fixation screws, femoral hip stems, femoral heads, and other hardware components. The purpose of the 510(k) is to assess the cross-compatibility of these physical devices.
Based on the provided text, the device described is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The intended use and indications for all the listed devices (BiPolar-i, Trinity Acetabular System, Corin MetaFix Hip Stem, MiniHip Stem, Trinity Dual Mobility System, Trinity PLUS Acetabular Shell, MobiliT Cup, Apex Hip System Bipolar Head, OMNI Hip system Ceramic Femoral Heads, OMNI Modular Hip Stems, Revival Modular Revision Hip Stem, TaperFirM Hip Stem, K 1 Hip arthroplasty, TriFit CF Hip Stem, Corin TriFit TSTM Hip arthroplasty) are all related to surgical implantation for the treatment of various hip conditions (osteoarthritis, avascular necrosis, fractures, deformities, revisions, etc.).
- Device Description: The device description details the components of hip implants (acetabular cups, liners, stems, heads, screws) and the materials they are made from. These are all physical components designed to be surgically placed within the body.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The provided text does not mention any examination of specimens outside the body.
Therefore, the devices described are implantable medical devices used in surgical procedures, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The BiPolar-i is intended for use in the following indications: Non-inflammatory degencrative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement, Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur, Revision of failed partial hip replacements in which the acetabulum does not require replacement. The BiPolar-i is indicated for cementless use only.
The Trinity Acetabular System is indicated for use in non-intlammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correctional deformity, developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH). The Trinity Acctabular System is intended for cementless, single use only.
The indications for the Corin MctaFixM Hip Stem as a total hip arthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union and femoral neck fractures, Developmental dysplasia of the hip (DDH) and congenital dysplasia of the hip (CDH). The Corin MetaFixTM Hip Stem is indicated for cementless use only.
The indications for the MiniHip Stem as a total hip arthroplasty include: Non-inflammatory degenerative joint disease including osteoarthriis and avascular necrosis Rheumatoid arthritis Correction of functional deformity. Developmental dysplasia of the hip (DDH) and congenital dysplasia of the hiniHip Stem is indicated for cementless use only.
The indications for the TrinityTM Accabular System as a total hip arthroplasty include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheunatoid arthritis, Correction of functional deformity, Developmental dysplasia of the hip (DDH), and congenital dysplasia of the hip (CDH). The Trinity Acctabular System is intended for cementless, single use only.
The Trinity Dual Mobility System is intended for use in the following indications: 1. Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis 2. Rheumatoid Arthritis 3. Correction of functional deformity 4. Revision of previously failed total hip arthroplasty 5. Patients at increased risk of dislocation 6. Developmental dysplasia of the hip (DDH). The Trinity TM Dual Mobility System is indicated for cementless use only.
The indications for the Corin Trinity™ PLUS Accabular Shell as a total hip arthroplasty include: Non-inflammalory degenerative joint disease including ostoarthritis and avascular necrosis. Rheumatoid arthritis. Correction of functional deformity, Revision of previously failed total hip arthroplasty, Developmental dysplasia of the hip (DDH). The Trinity TM PLUS Acctabular Shell is indicated for cement less use only.
The MobiliT Cup, for cemented and cementless use, are indicated for primary replacement of the hip joint: - In degenerative pathologies: primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis - For patients who have a high risk of dislocation - In cases of necrosis of the femoral head - In cases of fracture of the neck of the femur - In cases of congenital luxation. The MobiliT Cup, for cemented and cementless use, are indicated for revision when the bone tissue remains sufficient after the removal of the previous acetabular cup. The cementless MobiliT standard Cup, with flanges or with flanges and hook are indicated for cementless use only. The cemented MobiliT Cup is indicated for cemented use only.
The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: Femoral neck and trochanteric fractures of the proximal femur. Osteonecrosis of the femoral head, Revision procedures where other devices or treatments for these indications have failed.
The OMNI Hip system Ceramic Femoral Heads are intended for use in combination with the OMNI Hip System Stems as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with the OMNI Interface Acctabular System or bipolar component. This prosthesis is intended for single use may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fiactures of the proximal femur.
The indications for use of the OMNI Modular Hip Stems in hip arthroplasty include the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis: Correction of functional deformity; Congenital dislocation: Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The OMNI Modular Hip stems are indicated for cementless use only and single use implantation.
The Revival Modular Revision Hip Stem is indicated in revision surgery of femoral components, following failure of primary cemented or un-cemented prosthesis. The REVIVAL™ Hip Stem 100mm distal component is also indicated in primary total hip arthroplasty. The indications for the Revival™ Modular Revision Hip Stem include: Non-inflammatory degenerative joint disease including primary and secondary osteoarthritis. Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union and femoral neck fractment of traumatic dislocations of the hip, Failures of osteotomy, Treatment of arthrodesis. The Revival™ Revision Hip Stem is indicated for cementless, single use only.
TaperFirM Hip Stem is indicated for the relief of pain and restoration following the effects of femoral neck fracture, osteo, theumatory arthritis, post- traumatic disease effects, avascular necrosis and total hip revision. The Taper it Hip Stem is indicated for hemi-arthroplasty when used in combination with Corin hemiarthroplasty femoral heads. The TaperFitTM Hip Stem is indicated for cemented, single use only.
The indications for use of the K 1 Hip arthroplasty include the following conditions, as appropriate: Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis: Rheumatoid arthritis: Correction of functional deformity: Congenital disfocation: Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The K 1 Hip Stem is indicated for cementless use only and single use implantation.
The indications for the TriFit CF Hip Stem as a total hip arthroplasty and as a hip hemiarthroplasty include: Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union and femoral neck fractures, Developmental Dysplasia of the Hip (DDH), Previously failed hip surgery. The Trifit CF Hip Stem is indicated for cementless use only.
The indications for the Corin TriFit TSTM Hip atthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include: Non-inflammatory degenerative joint disease including osteoadhritis and avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur, Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH). The Tril'it TS Hip is intended for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
LZO, LPH, OQI, MEH, KWL, KWY, JDI, OQG, MBL
Device Description
The subject and predicate devices are one in the same and are comprised of several legally marketed Corin Ltd. hip products, which include OMNIIfe Sciences and Apex Surgical hip products. The subject devices include acetabular cups and liners, bone fixation screws, screw hole occluders, cemented and cementless femoral hip stems for primary and revision hip arthroplasty, fixation screws, modular necks, CoCrMo alloy and ceramic femoral heads, dual mobility acetabular systems, and bipolar heads. The purpose of this 510(k) is to notify the FDA of Corin's engineering assessment of the cross-compatibility of the subject devices, identification of conflicts, and updates to the product labeling. The subject hip devices components are manufactured from a variety of materials which include cobalt-chromium-molybdenum alloy, stainless steel alloy, unalloyed titanium, calcium phosphate (Bonit™ coating) Alumina Matrix Composite ceramic (Biolox Delta), and ultrahigh molecular weight polyethylene (UHMWPE), all of which conform to ASTM or ISO standards, or internal standards. The subject femoral hip stems and heads possess the same 12/14 taper design and reference system for determining head and neck offsets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral head, proximal femur, acetabulum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance characteristics of the subject devices were evaluated via engineering analyses to determine cross compatibility with each another. Assessment of product compatibility included the Corin and OMNI (and legacy Apex) modular heads, femoral stems, bone screws, and acetabular systems that are listed in Section C above. The compatibility assessment accounted for materials, geometry, design, and surface finish. More specifically, the subject devices were assessed for cross compatibility as follows:
- OMNI ARC hip stems, OMNI MOD hip stems and modular necks, OMNI K2 hip stems (standard and mid length) and modular necks, and OMNI K1 hip stems, To be indicated with: Corin Trinity Heads or OMNI Heads, Corin Trinity Acetabular system and cancellous bone screws, Corin Trinity Dual Mobility Acetabular system, Corin Dual Mobili-T Acetabular system, and Corin Bipolar-i.
- Corin MiniHip hip stems, Corin Revival hip stems, Corin TriFit (TS and CF) hip stems, Corin Taper Fit stems, Corin Metafix stems, To be indicated with: Corin Trinity Heads or OMNI Bipolar.
Drawing and CAD analyses were performed to identify differences between the specifications of modular head and stem taper designs for identification of potential conflicts (if any) on the safety and efficacy of the devices when used together. Performance testing was provided along with engineering analyses to leverage predicate testing results. Performance characteristics that were assessed for 'worst case' product type and size included the following:
- Ceramic head burst testing (ISO 7206-10).
- Head pull off and torque off testing (ISO 7206-10).
- Fretting-corrosion testing (ASTM F1875).
- Impingement testing of stem-cup combinations (ASTM F2582).
- Bi-polar head Lever-out and pullout testing.
- Comparison of Corin and OMNI male stem taper geometry and technical specification.
- Comparison of Corin and OMNI female modular head taper technical specifications.
- Comparison of Corin and OMNI CeramTec delta ceramic head drawings and offsets.
- Range of Motion assessment(ISO 21535) of OMNI stems with Corin acetabular systems.
- Assessment of interference for Corin modular heads assembled with OMNI femoral stems.
- Review of materials used for Corin and OMNI heads and stems.
- Comparison of Corin and OMNI stem trunnion and head taper engagement lengths.
- Engineering assessment of fatigue strength of hip stems for Corin and OMNI heads used with OMNI and Corin hip stems, and vice versa.
- An engineering review comparing the cancellous bone screws from OMNI and Corin.
- An engineering analysis to determine the effects of minimum diameter, worst-case congruency of the CoCr femoral heads with the Interface cup UHMWPE liners, on the contact areas, contact stresses, and wear potential at the head-liner interface.
Key Results: The bench testing, engineering analyses, and labeling presented in this 510(k) notification have established substantial equivalence of the subject and predicate Corin, OMNI, and Apex hip devices, including cross compatibility of use per the products' labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K093472, K110087, K111481, K122305, K123705, K130128, K130343, K131647
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K093472, K110087, K130343, K131647, K172551, K082525, K120362, K121439, K153381, K173880, K121563, K153772, K992234, K003666, K142761, K153725, K152903, K191374, K083312, K111046, K131986, K103120, K170359, K191831, K183114, K000788, K041950, K060072, K110947, K101451, K082468, K100151
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo is a stylized depiction of a human figure, while the FDA acronym and full name are written in blue, with the acronym in a blue square.
July 28, 2021
Corin Ltd. % Robert Poggie President BioVera Inc. 65 Promenade Saint Louis Notre Dame de LIle Perrot. Quebec J7V 7P2 Canada
Re: K201657
Trade/Device Name: Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, TrinityTM Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, LPH, OQI, MEH, KWL, KWY, JDI, OQG, MBL Dated: June 23, 2021 Received: June 24, 2021
Dear Robert Poggie:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
1
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Limin Sun, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
510(k) Number (if known) K201657
Device Name Corin BiPolar-i
Indications for Use (Describe)
The BiPolar-i is intended for use in the following indications: Non-inflammatory degencrative joint disease including osteoarthritis and avascular necrosis in which the acetabulum does not require replacement, Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur, Revision of failed partial hip replacements in which the acetabulum does not require replacement. The BiPolar-i is indicated for cementless use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
3
510(k) Number (if known) K201657
Device Name
Corin BIOLOX™ delta
Indications for Use (Describe)
The Trinity Acetabular System is indicated for use in non-intlammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correctional deformity, developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH). The Trinity Acctabular System is intended for cementless, single use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
4
510(k) Number (if known)
Device Name
Corin MetaFix TN Hip
Indications for Use (Describe)
The indications for the Corin MctaFixM Hip Stem as a total hip arthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include:
· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
· Rheumatoid arthritis
· Correction of functional deformity
· Treatment of non-union and femoral neck fractures
· Developmental dysplasia of the hip (DDH) and congenital dysplasia of the hip (CDH)
The Corin MetaFixTM Hip Stem is indicated for cementless use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
5
510(k) Number (if known) K201657
Device Name
Corin MiniHip™ Stem
Indications for Use (Describe)
The indications for the MiniHip Stem as a total hip arthroplasty include: Non-inflammatory degenerative joint disease including osteoarthriis and avascular necrosis Rheumatoid arthritis Correction of functional deformity. Developmental dysplasia of the hip (DDH) and congenital dysplasia of the hiniHip Stem is indicated for cementless use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
6
510(k) Number (if known)
Device Name
Corin Trinity TM Acetabular System
Indications for Use (Describe)
The indications for the TrinityTM Accabular System as a total hip arthroplasty include: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheunatoid arthritis, Correction of functional deformity, Developmental dysplasia of the hip (DDH), and congenital dysplasia of the hip (CDH). The Trinity Acctabular System is intended for cementless, single use only.
Type of Use (Select one or both, as applicable)> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the lime to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
7
510(k) Number (if known) K201657
Device Name
Corin Trinity TM Dual Mobility
Indications for Use (Describe)
The Trinity Dual Mobility System is intended for use in the following indications: 1. Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis 2. Rheumatoid Arthritis 3. Correction of functional deformity 4. Revision of previously failed total hip arthroplasty 5. Patients at increased risk of dislocation 6. Developmental dysplasia of the hip (DDH). The Trinity TM Dual Mobility System is indicated for cementless use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subparl D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
8
510(k) Number (if known) K 201657
Device Name
Corin Trinity TM PLUS Acetabular Shell
Indications for Use (Describe)
The indications for the Corin Trinity™ PLUS Accabular Shell as a total hip arthroplasty include: Non-inflammalory degenerative joint disease including ostoarthritis and avascular necrosis. Rheumatoid arthritis. Correction of functional deformity, Revision of previously failed total hip arthroplasty, Developmental dysplasia of the hip (DDH). The Trinity TM PLUS Acctabular Shell is indicated for cement less use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
9
510(k) Number (if known) K201657
Device Name
MobiliTTM Cup and Dual Mobility accetabular cups
Indications for Use (Describe)
The MobiliT Cup, for cemented and cementless use, are indicated for primary replacement of the hip joint: - In degenerative pathologies: primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis
- For patients who have a high risk of dislocation
- In cases of necrosis of the femoral head
- In cases of fracture of the neck of the femur
- In cases of congenital luxation
The MobiliT Cup, for cemented and cementless use, are indicated for revision when the bone tissue remains sufficient after the removal of the previous acetabular cup.
The cementless MobiliT standard Cup, with flanges or with flanges and hook are indicated for cementless use only.
The cemented MobiliT Cup is indicated for cemented use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
10
510(k) Number (if known) K201657
Device Name
OMNI Bipolar Head
Indications for Use (Describe)
The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: Femoral neck and trochanteric fractures of the proximal femur. Osteonecrosis of the femoral head, Revision procedures where other devices or treatments for these indications have failed.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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11
510(k) Number (if known) K 201657
Device Name
OMNI Delta Ceramic Femoral Head The OMNI Hip system Ceramic Femoral Heads
Indications for Use (Describe)
The OMNI Hip system Ceramic Femoral Heads are intended for use in combination with the OMNI Hip System Stems as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with the OMNI Interface Acctabular System or bipolar component. This prosthesis is intended for single use may be used for the following conditions, as appropriate:
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; .
- . Rheumatoid arthritis;
- . Correction of functional deformity;
- . Congenital dislocation;
- Revision procedures where other treatments or devices have failed;
- Femoral neck and trochanteric fiactures of the proximal femur.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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12
510(k) Number (if known) K201657
Device Name
OMNI MOD and OMNI Modular Hin; OMNI K2 Stem
Indications for Use (Describe)
The indications for use of the OMNI Modular Hip Stems in hip arthroplasty include the following conditions, as appropriate:
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis:
- Correction of functional deformity;
- Congenital dislocation:
- Revision procedures where other treatments or devices have failed;
- Femoral neck and trochanteric fractures of the proximal femur.
The OMNI Modular Hip stems are indicated for cementless use only and single use implantation.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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13
K201657
510(k) Number (if known)
Device Name
OMNI MOD™ Hip
Indications for Use (Describe)
The indications for use of the OMNI Modular Hip Stems in hip arthroplasty include the following conditions, as appropriate:
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis:
- Correction of functional deformity;
- Congenital dislocation:
- Revision procedures where other treatments or devices have failed;
- Femoral neck and trochanteric fractures of the proximal femur.
The OMNI Modular Hip stems are indicated for cementless use only and single use implantation.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
14
510(k) Number (if known) K201657
Device Name
Corin Revival™ Hip
Indications for Use (Describe)
The Revival Modular Revision Hip Stem is indicated in revision surgery of femoral components, following failure of primary cemented or un-cemented prosthesis. The REVIVAL™ Hip Stem 100mm distal component is also indicated in primary total hip arthroplasty. The indications for the Revival TM Modular Revision Hip Stem include: Non-inflammatory degenerative joint disease including primary and secondary osteoarthritis. Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union and femoral neck fractment of traumatic dislocations of the hip, Failures of osteotomy, Treatment of arthrodesis. The Revival ™ Revision Hip Stem is indicated for cementless, single use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
15
510(k) Number (if known)
Device Name
Corin TaperFitTM
Indications for Use (Describe)
TaperFirM Hip Stem is indicated for the relief of pain and restoration following the effects of femoral neck fracture, osteo, theumatory arthritis, post- traumatic disease effects, avascular necrosis and total hip revision. The Taper it Hip Stem is indicated for hemi-arthroplasty when used in combination with Corin hemiarthroplasty femoral heads.
The TaperFitTM Hip Stem is indicated for cemented, single use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
16
510(k) Number (if known) K201657
Device Name
OMNI K1 Hip System
Indications for Use (Describe)
The indications for use of the K 1 Hip arthroplasty include the following conditions, as appropriate: Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis: Rheumatoid arthritis: Correction of functional deformity: Congenital disfocation: Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The K 1 Hip Stem is indicated for cementless use only and single use implantation.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
17
K201657
510(k) Number (if known)
Device Name
Corin TriFit CF Hip
Indications for Use (Describe)
The indications for the TriFit CF Hip Stem as a total hip arthroplasty and as a hip hemiarthroplasty include: Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union and femoral neck fractures, Developmental Dysplasia of the Hip (DDH), Previously failed hip surgery. The Trifit CF Hip Stem is indicated for cementless use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
18
510(k) Number (if known) K 201657
Device Name
Corin TriFit TSTM Hip
Indications for Use (Describe)
The indications for the Corin TriFit TSTM Hip atthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include: Non-inflammatory degenerative joint disease including osteoadhritis and avascular necrosis, Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur, Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH). The Tril'it TS Hip is intended for cementless use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
19
510(k) SUMMARY
Cross Compatibility of Corin Ltd. and OMNIIife Sciences Hip Products
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness of the subject Corin hip devices.
A. SUBMISSION CORRESPONDENCE
| Prepared By: | BioVera, Inc. |
|---|---|
| Submitter Address: | 65 Promenade Saint-Louis, Notre-Dame-De-L'Ile-Perrot, Quebec, J7V |
| 7P2, CANADA | |
| Contact Person: | Robert A Poggie, PhD |
| Phone & Fax Number: | (514) 901-0796 |
| Date of Submission: | June 23, 2021 |
B. DEVICE IDENTIFICATION & MANUFACTURER (Submission Sponsor)
| Manufacturer Name: | Corin Ltd. |
|---|---|
| Manufacturer Address: | 480 Paramount Drive, Raynham, MA, 02767, USA |
| Registration Number: | 1226188 |
| Contact Name: | Christina Rovaldi |
| Title: | Regulatory Affairs Specialist |
| Device Trade Names: | Corin Ltd. Hip Products: TrinityTM Acetabular System, TrinityTM PLUS |
| Acetabular Shell, MetaFixTM Hip System, TriFitTM CF and TS Hip | |
| Systems, TaperFitTM Hip System, RevivalTM Modular Hip System, | |
| MiniHipTM, TrinityTM Dual Mobility, MobiliT, BiPolar-i, OMNI MODTM | |
| Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, | |
| Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads. | |
| Device Common | |
| Names: | Hip prosthesis, femoral hip stem, acetabular cup, acetabular shell, |
| acetabular liner, bipolar head, dual mobility cup | |
| Classification Names: | LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer, |
| cemented or non-porous, uncemented; | |
| LPH - prosthesis, hip, semi-constrained, metal/polymer, porous | |
| uncemented | |
| OQI - hip, semi-constrained, cemented, metal/ceramic/polymer + | |
| additive, porous uncemented | |
| MEH - Prosthesis, hip, semi-constrained, uncemented, metal / | |
| polymer, non-porous, calcium phosphate; | |
| JDI - Prosthesis, hip, semi-constrained, metal/polymer, cemented; | |
| KWL - Prosthesis, hip, femoral component, cemented, metal; |
20
| | KWY - Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or
uncemented; |
|-----------------------|---------------------------------------------------------------------------------------------------|
| | OQG - hip prosthesis, semi-constrained, cemented, metal/polymer,
additive, porous, uncemented; |
| | MBL - prosthesis, hip, semi-constrained, uncemented, metal/polymer,
porous. |
| Classification Codes: | LZO, LPH, OQI, MEH, KWL, KWY, JDI, OQG, MBL, all class II |
| Classification Panel: | Orthopaedic |
| Regulation Numbers: | 21 CFR 888.3353, 888.3358, 888.3390, 888.3350, 888.3360 |
C. PREDICATE DEVICES
| K093472, K110087, | Primary Predicate Device: |
|---|---|
| K111481, K122305, | |
| K123705, K130128, | |
| K130343, K131647 | Corin Trinity Acetabular System, including acetabular shells of various |
| configurations, femoral heads, bone screws, hole occluders, and | |
| HXLPE and ecima acetabular liners | |
| Secondary Predicate Devices: | |
| K093472, K110087, | |
| K130343, K131647 | Corin CoCrMo femoral heads, various diameters and offsets |
| K172551 | Corin PLUS Acetabular Shell |
| K082525, K120362, | |
| K121439, K153381 | Corin MetaFix Hip System |
| K173880 | Corin TriFit CF Hip System |
| K121563, K153772 | Corin TriFit TS Hip System |
| K992234, K003666, | |
| K142761, K153725 | Corin TaperFit Hip System |
| K152903, K191374 | Corin Revival Modular Hip System |
| K083312, K111046, | |
| K131986 | Corin MiniHip |
| K103120 | Corin Biolox Delta femoral heads |
| K170359 | Corin Trinity Dual Mobility System |
| K191831 | Corin MobiliT Cup |
| K183114 | Corin BiPolar-i |
| K000788 | OMNI MOD Hip System (formerly Apex) |
| K041950 | OMNI K2 Hip System (formerly Apex, now OMNI MOD) |
| K060072, K110947 | OMNI K1 Hip System |
| K101451 | OMNI Delta Ceramic Head (originally trade named Apex) |
| K082468, K100151 | OMNI Hip System Bipolar Head |
21
D. DEVICE DESCRIPTION
The subject and predicate devices are one in the same and are comprised of several legally marketed Corin Ltd. hip products, which include OMNIIfe Sciences and Apex Surgical hip products. The subject devices include acetabular cups and liners, bone fixation screws, screw hole occluders, cemented and cementless femoral hip stems for primary and revision hip arthroplasty, fixation screws, modular necks, CoCrMo alloy and ceramic femoral heads, dual mobility acetabular systems, and bipolar heads. The purpose of this 510(k) is to notify the FDA of Corin's engineering assessment of the cross-compatibility of the subject devices, identification of conflicts, and updates to the product labeling.
The subject hip devices components are manufactured from a variety of materials which include cobalt-chromium-molybdenum alloy, stainless steel alloy, unalloyed titanium, calcium phosphate (Bonit™ coating) Alumina Matrix Composite ceramic (Biolox Delta), and ultrahigh molecular weight polyethylene (UHMWPE), all of which conform to ASTM or ISO standards, or internal standards. The subject femoral hip stems and heads possess the same 12/14 taper design and reference system for determining head and neck offsets.
E. INTENDED USE
The Corin Ltd. hip products are single use only devices. The indications for use for the predicate and subject devices are the same as provided in the table below.
| 510(k) number(s)
| Product name | Indications for Use |
|---|---|
| K093472, K110087, | |
| K111481, K122305, | |
| K123705, K130128, | |
| K130343, K131647 | |
| Corin Trinity™ | |
| Acetabular System | |
| Including CoCrMo | |
| femoral heads in | |
| K093472, K110087, | |
| K130343, K131647 | The indications for the Trinity™ Acetabular System as a total hip arthroplasty |
| include: Non-inflammatory degenerative joint disease including osteoarthritis | |
| and avascular necrosis, Rheumatoid arthritis, Correction of functional | |
| deformity, Developmental dysplasia of the hip (DDH), and congenital dysplasia | |
| of the hip (CDH). The Trinity Acetabular System is intended for cementless use | |
| only. | |
| K172551 | |
| Corin Trinity™ PLUS | |
| Acetabular Shell | The indications for the Corin Trinity™ PLUS Acetabular Shell as a total hip |
| arthroplasty include: Non-inflammatory degenerative joint disease including | |
| osteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction of | |
| functional deformity, Revision of previously failed total hip arthroplasty, | |
| Developmental dysplasia of the hip (DDH). The Trinity™ PLUS Acetabular | |
| Shell is indicated for cementless use only. | |
| K082525, K120362, | |
| K121439, K153381 | |
| Corin MetaFix™ Hip | The indications for the Corin MetaFix™ Hip Stem as a total hip arthroplasty, |
| and when used in combination with a Corin hemi arthroplasty head, as a | |
| hip hemi-arthroplasty, include: Non-inflammatory degenerative joint disease | |
| including osteoarthritis and avascular necrosis, Rheumatoid arthritis, | |
| Correction of functional deformity, Treatment of non-union and femoral neck | |
| fractures, Developmental dysplasia of the hip (DDH) and congenital dysplasia | |
| of the hip (CDH). The Corin Metafix Hip Stem is indicated for cementless use | |
| only. | |
| K173880 | |
| Corin TriFit CF™ Hip | The indications for the Corin TriFit™ CF Hip Stem as a total hip arthroplasty |
| and as a hip hemiarthroplasty include: Non-inflammatory degenerative joint | |
| disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; | |
| Correction of functional deformity; Treatment of non-union and femoral neck | |
| fractures of the proximal femur; Developmental Dysplasia of the Hip (DDH); | |
| Previously failed hip surgery. The Corin TriFit™ CF Hip Stem is indicated for | |
| cementless use only. | |
| K121563, K153772, | |
| Corin TriFit TS™ Hip | The indications for the Corin TriFit TS™ Hip as a total hip arthroplasty, and |
| when used in combination with a Corin hemi arthroplasty head, as a hip hemi- | |
| arthroplasty, include: Non-inflammatory degenerative joint disease including | |
| osteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction of | |
| functional deformity, Treatment of non-union, femoral neck and trochanteric | |
| fractures of the proximal femur, Developmental dysplasia of the hip (DDH) or | |
| congenital dysplasia of the hip (CDH). The TriFit TS Hip is intended for | |
| cementless use only. | |
| K992234, K003666, | |
| K142761, K153725 | |
| Corin TaperFit™ | TaperFit™ Hip Stem is indicated for the relief of pain and restoration of hip |
| function following the effects of osteo, rheumatoid and inflammatory | |
| arthritis, post-traumatic disease effects, avascular necrosis and total hip | |
| revision. The TaperFit Hip Stem is indicated for hemi-arthroplasty when used in | |
| combination with Corin hemi-arthroplasty femoral heads. The TaperFit Hip | |
| Stem is indicated for cemented, single use only. | |
| K152903, K191374 | |
| Corin Revival™ | |
| Modular Hip Stem | The Revival™ Modular Revision Hip Stem is indicated in revision surgery |
| of femoral components, following failure of primary cemented or un-cemented | |
| prosthesis. The REVIVAL™ Modular Hip Stem 100mm distal component is | |
| also indicated in primary total hip arthroplasty. The indications for the Revival | |
| ™ Modular Revision Hip Stem include: Non-inflammatory degenerative | |
| joint disease including primary and secondary osteoarthritis and hip | |
| dysplasia, Aseptic necrosis of the femoral head, Rheumatoid arthritis, | |
| Correction of functional deformity, Treatment of non-union and femoral neck | |
| fractures, Treatment of traumatic dislocations of the hip, Failures of osteotomy, | |
| Treatment of arthrodesis. The Revival ™ Modular Revision Hip Stem is | |
| indicated for cementless, single use only. | |
| K083312, K111046, | |
| K131986 | |
| Corin MiniHip™ Stem | The indications for the MiniHip™ Stem as a total hip arthroplasty include: Non- |
| inflammatory degenerative joint disease including osteoarthritis and avascular | |
| necrosis, Rheumatoid arthritis, Correction of functional deformity, | |
| Developmental dysplasia of the hip (DDH) and congenital dysplasia of the hip | |
| (CDH), The MiniHip Stem is indicated for cementless use only. | |
| K103120 | |
| Corin BIOLOX™ | |
| delta | The Trinity™ Acetabular System is indicated for use in non-inflammatory |
| degenerative joint disease including osteoarthritis and avascular necrosis, | |
| rheumatoid arthritis, correction of functional deformity, developmental | |
| dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH). The Trinity | |
| Acetabular System is intended for cementless, single use only. | |
| K170359 | |
| Corin Trinity™ Dual | |
| Mobility | The Trinity™ Dual Mobility System is intended for use in the following |
| indications: 1. Non-inflammatory degenerative joint disease, including | |
| osteoarthritis & avascular necrosis 2. Rheumatoid Arthritis 3. Correction of | |
| functional deformity 4. Revision of previously failed total hip arthroplasty 5. | |
| Patients at increased risk of dislocation 6. Developmental dysplasia of the hip | |
| (DDH). The Trinity™ Dual Mobility System is indicated for cementless use only. | |
| K191831 | |
| MobiliT™ Cup | The MobiliT™ Cup, for cemented and cementless use, are indicated for primary |
| replacement of the hip joint: - In degenerative pathologies: primary, secondary | |
| or post-traumatic osteoarthritis, rheumatoid arthritis- For patients who have a | |
| high risk of dislocation. In cases of necrosis of the femoral head. In cases of | |
| fracture of the neck of the femur- In cases of congenital luxation. The | |
| MobiliT™ Cup, for cemented and cementless use, are indicated for revision | |
| when the bone tissue remains sufficient after the removal of the previous | |
| acetabular cup. The cementless MobiliT™ standard Cup, with flanges or with | |
| flanges and hook are indicated for cementless use only. The cemented | |
| MobiliT™ Cup is indicated for cemented use only. | |
| K183114 | |
| Corin BiPolar-i | The BiPolar-i is intended for use in the following indications: Non-inflammatory |
| degenerative joint disease including osteoarthritis and avascular necrosis in | |
| which the acetabulum does not require replacement, Treatment of non-union, | |
| femoral neck and trochanteric fractures of the proximal femur, Revision of | |
| failed partial hip replacements in which the acetabulum does not require | |
| replacement. The BiPolar-i is indicated for cementless use only. | |
| K000788 | |
| OMNI MOD™™ Hip | |
| System was formerly | |
| the Apex Modular hip | |
| Including CoCrMo | |
| femoral heads | The indications for use of the OMNI Modular Hip Stems in hip arthroplasty |
| include the following conditions; as appropriate: Non-inflammatory | |
| degenerative joint disease, including osteoarthritis and avascular necrosis; | |
| Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; | |
| Revision procedures where other treatments or devices have failed; Femoral | |
| neck and trochanteric fractures of the proximal femur. | |
| The OMNI modular hip stems are indicated for cementless use only and single | |
| use implantation. | |
| K041950 | |
| OMNI K2 Hip was | |
| originally Apex K2 hip | |
| OMNI Modular Hip | |
| was originally Apex | |
| Modular hip system | |
| Both stems trade | |
| named OMNI | The indications for use of the OMNI Modular Hip Stems in hip arthroplasty |
| include the following conditions, as appropriate: Non-inflammatory | |
| degenerative joint disease, including osteoarthritis and avascular necrosis; | |
| Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; | |
| Revision procedures where other treatments or devices have failed; Femoral | |
| neck and trochanteric fractures of the proximal femur. | |
| The OMNI Modular Hip stems are indicated for cementless use only and single | |
| use implantation | |
| K060072, K110947 | |
| OMNI K1 Hip System | The indications for use of the K1 Hip Stem in hip arthroplasty include the |
| following conditions, as appropriate: Non-inflammatory degenerative joint | |
| disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; | |
| Correction of functional deformity; Congenital dislocation; Revision procedures | |
| where other treatments or devices have failed; Femoral neck and trochanteric | |
| fractures of the proximal femur. The K1 Hip Stem is indicated for cementless | |
| use only and single use implantation. | |
| K101451 | |
| OMNI Delta Ceramic | |
| Femoral Head | |
| (originally trade | |
| named Apex) | The OMNI Hip system Ceramic Femoral Heads are intended for use in |
| combination with the OMNI Hip System Stems as the femoral component in total | |
| hip replacement procedures. This ceramic head is intended to articulate with | |
| OMNI Interface Acetabular System or bipolar component. This prosthesis is | |
| intended for single use implantation, and may be used for the following | |
| conditions, as appropriate: Non-inflammatory degenerative joint disease, | |
| including osteoarthritis and avascular necrosis, Rheumatoid arthritis, | |
| Correction of functional deformity, Congenital dislocation. Revision procedures | |
| where other treatments or devices have failed, Femoral neck and trochanteric | |
| fractures of the proximal femur. | |
| K082468, K100151 | |
| OMNI Bipolar Head | The Apex Hip System Bipolar Head is intended for use in combination with an |
| Apex Hip System femoral stem for uncemented primary or revision | |
| hemiarthroplasty of the hip. This prosthesis may be used for the following | |
| conditions, as appropriate: Femoral neck and trochanteric fractures of the | |
| proximal femur, Osteonecrosis of the femoral head, Revision procedures | |
| where other devices or treatments for these indications have failed. |
22
23
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F. TECHNOLOGICAL CHARACTERISTICS
The subject hip devices are indicated for use in primary and revision hip surgery, hemiarthroplasty, and total hip replacement, and are offered in various sizes, materials, and configurations to accommodate patient anatomy, clinical condition, and surgeon preference. The indications for use for the subject devices are provided in the table above, and are the same as the predicate devices. The devices are unchanged except for updates to the labeling of the devices where engineering analysis indicated conflict relative to cross compatibility with other subject devices. Corin engineering analyses established cross compatibility of the subject devices, with the few exceptions noted in the products' labeling.
G. PERFORMANCE DATA
The performance characteristics of the subject devices were evaluated via engineering analyses to determine cross compatibility with each another. Assessment of product compatibility included the Corin and OMNI (and legacy Apex) modular heads, femoral stems, bone screws, and acetabular systems that are listed in Section C above. The compatibility assessment accounted for materials, geometry, design, and surface finish. More specifically, the subject devices were assessed for cross compatibility as follows:
- OMNI ARC hip stems, OMNI MOD hip stems and modular necks, OMNI K2 hip stems (standard and mid length) and modular necks, and OMNI K1 hip stems, To be indicated with: Corin Trinity Heads or OMNI Heads, Corin Trinity Acetabular system and cancellous bone screws, Corin Trinity Dual Mobility Acetabular system, Corin Dual Mobili-T Acetabular system, and Corin Bipolar-i.
- · Corin MiniHip hip stems, Corin Revival hip stems, Corin TriFit (TS and CF) hip stems, Corin Taper Fit stems, Corin Metafix stems, To be indicated with: Corin Trinity Heads or OMNI Bipolar.
Drawing and CAD analyses were performed to identify differences between the specifications of modular head and stem taper designs for identification of potential conflicts (if any) on the safety and efficacy of the devices when used together. Performance testing was provided along with engineering analyses to leverage predicate testing results. Performance characteristics that were assessed for 'worst case' product type and size included the following:
- · Ceramic head burst testing (ISO 7206-10).
- · Head pull off and torque off testing (ISO 7206-10).
- · Fretting-corrosion testing (ASTM F1875).
- · Impingement testing of stem-cup combinations (ASTM F2582).
- · Bi-polar head Lever-out and pullout testing.
- Comparison of Corin and OMNI male stem taper geometry and technical specification.
- · Comparison of Corin and OMNI female modular head taper technical specifications.
- · Comparison of Corin and OMNI CeramTec delta ceramic head drawings and offsets.
- · Range of Motion assessment(ISO 21535) of OMNI stems with Corin acetabular systems.
- · Assessment of interference for Corin modular heads assembled with OMNI femoral stems.
- · Review of materials used for Corin and OMNI heads and stems.
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- · Comparison of Corin and OMNI stem trunnion and head taper engagement lengths.
- · Engineering assessment of fatigue strength of hip stems for Corin and OMNI heads used with OMNI and Corin hip stems, and vice versa.
- · An engineering review comparing the cancellous bone screws from OMNI and Corin.
- · An engineering analysis to determine the effects of minimum diameter, worst-case congruency of the CoCr femoral heads with the Interface cup UHMWPE liners, on the contact areas, contact stresses, and wear potential at the head-liner interface.
H. CONCLUSION
The bench testing, engineering analyses, and labeling presented in this 510(k) notification have established substantial equivalence of the subject and predicate Corin, OMNI, and Apex hip devices, including cross compatibility of use per the products' labeling.