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 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.

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.

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.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria and study proving device performance as typically seen in a medical device submission beyond general statements of substantial equivalence. The document is a 510(k) summary for hip replacement components, primarily focusing on cross-compatibility of various existing devices.

The text outlines:

Device identification and manufacturer information.
List of numerous predicate devices.
Detailed descriptions of the indications for use for many hip components (e.g., Corin BiPolar-i, Trinity™ Acetabular System, MetaFix™ Hip, MiniHip™, Trinity™ Dual Mobility, MobiliT™ Cup, OMNI Bipolar Head, OMNI Delta Ceramic Femoral Head, OMNI MOD Hip System, OMNI K1/K2 Hip Systems, Revival™ Modular Hip Stem, TaperFit™, TriFit™ CF/TS Hip). These indications primarily relate to non-inflammatory degenerative joint disease, rheumatoid arthritis, correction of functional deformity, avascular necrosis, fractures, and revision surgeries.
A "Performance Data" section which describes the types of engineering analyses and bench testing performed to establish cross-compatibility (e.g., ceramic head burst testing, head pull-off, fretting-corrosion, impingement testing, range of motion assessment, comparison of taper geometries, fatigue strength assessment, and contact stress/wear potential).

However, it does not provide:

A specific table of acceptance criteria and reported device performance for the types of tests mentioned (e.g., what burst pressure was required vs. achieved). It only lists the types of tests done.
Sample sizes used for test sets or data provenance.
Number of experts and their qualifications for establishing ground truth (as this pertains to clinical studies, which are not detailed here for performance).
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study information.
Standalone algorithm performance (as this is not an AI/algorithm-driven device).
Type of ground truth used (again, this is not a diagnostic device with "ground truth" in the typical sense).
Sample size for training set.
How ground truth for the training set was established.

The document's purpose is to demonstrate substantial equivalence of a range of hip components, including their cross-compatibility when used together. The "performance data" refers to the engineering and bench testing conducted to ensure this compatibility rather than clinical performance against specific metrics as one would find for a diagnostic or AI-driven device.

Summary

{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)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

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:

{3}------------------------------------------------

510(k) Number (if known) K201657

Device Name

Corin BIOLOX™ delta

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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 .

{4}------------------------------------------------

510(k) Number (if known)

K201657

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)

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 .

{5}------------------------------------------------

510(k) Number (if known) K201657

Device Name

Corin MiniHip™ Stem

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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 .

{6}------------------------------------------------

510(k) Number (if known)

K201657

Device Name

Corin Trinity TM Acetabular System

Indications for Use (Describe)

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:

{7}------------------------------------------------

510(k) Number (if known) K201657

Device Name

Corin Trinity TM Dual Mobility

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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 .

{8}------------------------------------------------

510(k) Number (if known) K 201657

Device Name

Corin Trinity TM PLUS Acetabular Shell

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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 .

{9}------------------------------------------------

510(k) Number (if known) K201657

Device Name

MobiliTTM Cup and Dual Mobility accetabular cups

Indications for Use (Describe)

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)

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 .

{10}------------------------------------------------

510(k) Number (if known) K201657

Device Name

OMNI Bipolar Head

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

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 .

{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)

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)

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 .

{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)

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 .

{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)

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 .

{14}------------------------------------------------

510(k) Number (if known) K201657

Device Name

Corin Revival™ Hip

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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 .

{15}------------------------------------------------

510(k) Number (if known)

K201657

Device Name

Corin TaperFitTM

Indications for Use (Describe)

The TaperFitTM Hip Stem is indicated for cemented, single use only.

Type of Use (Select one or both, as applicable)

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 .

{16}------------------------------------------------

510(k) Number (if known) K201657

Device Name

OMNI K1 Hip System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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 .

{17}------------------------------------------------

K201657

510(k) Number (if known)

Device Name

Corin TriFit CF Hip

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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 .

{18}------------------------------------------------

510(k) Number (if known) K 201657

Device Name

Corin TriFit TSTM Hip

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

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 .

{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, J7V7P2, 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 PLUSAcetabular Shell, MetaFixTM Hip System, TriFitTM CF and TS HipSystems, TaperFitTM Hip System, RevivalTM Modular Hip System,MiniHipTM, TrinityTM Dual Mobility, MobiliT, BiPolar-i, OMNI MODTMHip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads,Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads.
Device CommonNames:	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, porousuncementedOQI - hip, semi-constrained, cemented, metal/ceramic/polymer +additive, porous uncementedMEH - 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 oruncemented;
	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 variousconfigurations, femoral heads, bone screws, hole occluders, andHXLPE 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 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, K131647Corin Trinity™Acetabular SystemIncluding CoCrMofemoral heads inK093472, K110087,K130343, K131647	The indications for the Trinity™ Acetabular System as a total hip arthroplastyinclude: Non-inflammatory degenerative joint disease including osteoarthritisand avascular necrosis, Rheumatoid arthritis, Correction of functionaldeformity, Developmental dysplasia of the hip (DDH), and congenital dysplasiaof the hip (CDH). The Trinity Acetabular System is intended for cementless useonly.
K172551Corin Trinity™ PLUSAcetabular Shell	The indications for the Corin Trinity™ PLUS Acetabular Shell as a total hiparthroplasty include: Non-inflammatory degenerative joint disease includingosteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction offunctional deformity, Revision of previously failed total hip arthroplasty,Developmental dysplasia of the hip (DDH). The Trinity™ PLUS AcetabularShell is indicated for cementless use only.
K082525, K120362,K121439, K153381Corin 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 ahip hemi-arthroplasty, include: Non-inflammatory degenerative joint diseaseincluding osteoarthritis and avascular necrosis, Rheumatoid arthritis,Correction of functional deformity, Treatment of non-union and femoral neckfractures, Developmental dysplasia of the hip (DDH) and congenital dysplasiaof the hip (CDH). The Corin Metafix Hip Stem is indicated for cementless useonly.
K173880Corin TriFit CF™ Hip	The indications for the Corin TriFit™ CF Hip Stem as a total hip arthroplastyand as a hip hemiarthroplasty include: Non-inflammatory degenerative jointdisease including osteoarthritis and avascular necrosis; Rheumatoid arthritis;Correction of functional deformity; Treatment of non-union and femoral neckfractures of the proximal femur; Developmental Dysplasia of the Hip (DDH);Previously failed hip surgery. The Corin TriFit™ CF Hip Stem is indicated forcementless use only.
K121563, K153772,Corin TriFit TS™ Hip	The indications for the Corin TriFit TS™ Hip as a total hip arthroplasty, andwhen used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include: Non-inflammatory degenerative joint disease includingosteoarthritis and avascular necrosis, Rheumatoid arthritis, Correction offunctional deformity, Treatment of non-union, femoral neck and trochantericfractures of the proximal femur, Developmental dysplasia of the hip (DDH) orcongenital dysplasia of the hip (CDH). The TriFit TS Hip is intended forcementless use only.
K992234, K003666,K142761, K153725Corin TaperFit™	TaperFit™ Hip Stem is indicated for the relief of pain and restoration of hipfunction following the effects of osteo, rheumatoid and inflammatoryarthritis, post-traumatic disease effects, avascular necrosis and total hiprevision. The TaperFit Hip Stem is indicated for hemi-arthroplasty when used incombination with Corin hemi-arthroplasty femoral heads. The TaperFit HipStem is indicated for cemented, single use only.
K152903, K191374Corin Revival™Modular Hip Stem	The Revival™ Modular Revision Hip Stem is indicated in revision surgeryof femoral components, following failure of primary cemented or un-cementedprosthesis. The REVIVAL™ Modular Hip Stem 100mm distal component isalso indicated in primary total hip arthroplasty. The indications for the Revival™ Modular Revision Hip Stem include: Non-inflammatory degenerativejoint disease including primary and secondary osteoarthritis and hipdysplasia, Aseptic necrosis of the femoral head, Rheumatoid arthritis,Correction of functional deformity, Treatment of non-union and femoral neckfractures, Treatment of traumatic dislocations of the hip, Failures of osteotomy,Treatment of arthrodesis. The Revival ™ Modular Revision Hip Stem isindicated for cementless, single use only.
K083312, K111046,K131986Corin MiniHip™ Stem	The indications for the MiniHip™ Stem as a total hip arthroplasty include: Non-inflammatory degenerative joint disease including osteoarthritis and avascularnecrosis, 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.
K103120Corin BIOLOX™delta	The Trinity™ Acetabular System is indicated for use in non-inflammatorydegenerative joint disease including osteoarthritis and avascular necrosis,rheumatoid arthritis, correction of functional deformity, developmentaldysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH). The TrinityAcetabular System is intended for cementless, single use only.
K170359Corin Trinity™ DualMobility	The Trinity™ Dual Mobility System is intended for use in the followingindications: 1. Non-inflammatory degenerative joint disease, includingosteoarthritis & avascular necrosis 2. Rheumatoid Arthritis 3. Correction offunctional 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.
K191831MobiliT™ Cup	The MobiliT™ Cup, for cemented and cementless use, are indicated for primaryreplacement of the hip joint: - In degenerative pathologies: primary, secondaryor post-traumatic osteoarthritis, rheumatoid arthritis- For patients who have ahigh 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. TheMobiliT™ Cup, for cemented and cementless use, are indicated for revisionwhen the bone tissue remains sufficient after the removal of the previousacetabular cup. The cementless MobiliT™ standard Cup, with flanges or withflanges and hook are indicated for cementless use only. The cementedMobiliT™ Cup is indicated for cemented use only.
K183114Corin BiPolar-i	The BiPolar-i is intended for use in the following indications: Non-inflammatorydegenerative joint disease including osteoarthritis and avascular necrosis inwhich the acetabulum does not require replacement, Treatment of non-union,femoral neck and trochanteric fractures of the proximal femur, Revision offailed partial hip replacements in which the acetabulum does not requirereplacement. The BiPolar-i is indicated for cementless use only.
K000788OMNI MOD™™ HipSystem was formerlythe Apex Modular hipIncluding CoCrMofemoral heads	The indications for use of the OMNI Modular Hip Stems in hip arthroplastyinclude the following conditions; as appropriate: Non-inflammatorydegenerative joint disease, including osteoarthritis and avascular necrosis;Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation;Revision procedures where other treatments or devices have failed; Femoralneck and trochanteric fractures of the proximal femur.The OMNI modular hip stems are indicated for cementless use only and singleuse implantation.
K041950OMNI K2 Hip wasoriginally Apex K2 hipOMNI Modular Hipwas originally ApexModular hip systemBoth stems tradenamed OMNI	The indications for use of the OMNI Modular Hip Stems in hip arthroplastyinclude the following conditions, as appropriate: Non-inflammatorydegenerative joint disease, including osteoarthritis and avascular necrosis;Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation;Revision procedures where other treatments or devices have failed; Femoralneck and trochanteric fractures of the proximal femur.The OMNI Modular Hip stems are indicated for cementless use only and singleuse implantation
K060072, K110947OMNI K1 Hip System	The indications for use of the K1 Hip Stem in hip arthroplasty include thefollowing conditions, as appropriate: Non-inflammatory degenerative jointdisease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis;Correction of functional deformity; Congenital dislocation; Revision procedureswhere other treatments or devices have failed; Femoral neck and trochantericfractures of the proximal femur. The K1 Hip Stem is indicated for cementlessuse only and single use implantation.
K101451OMNI Delta CeramicFemoral Head(originally tradenamed Apex)	The OMNI Hip system Ceramic Femoral Heads are intended for use incombination with the OMNI Hip System Stems as the femoral component in totalhip replacement procedures. This ceramic head is intended to articulate withOMNI Interface Acetabular System or bipolar component. This prosthesis isintended for single use implantation, and may be used for the followingconditions, as appropriate: Non-inflammatory degenerative joint disease,including osteoarthritis and avascular necrosis, Rheumatoid arthritis,Correction of functional deformity, Congenital dislocation. Revision procedureswhere other treatments or devices have failed, Femoral neck and trochantericfractures of the proximal femur.
K082468, K100151OMNI Bipolar Head	The Apex Hip System Bipolar Head is intended for use in combination with anApex Hip System femoral stem for uncemented primary or revisionhemiarthroplasty of the hip. This prosthesis may be used for the followingconditions, as appropriate: Femoral neck and trochanteric fractures of theproximal femur, Osteonecrosis of the femoral head, Revision procedureswhere other devices or treatments for these indications have failed.

{22}------------------------------------------------

{23}------------------------------------------------

{24}------------------------------------------------

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.

{25}------------------------------------------------

· 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.

Regulation Number and Section

§ 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.