(171 days)
No
The document describes a physical hip implant and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The submission focuses on labeling modifications for compatible femoral heads.
Yes
The device is a component of a total hip arthroplasty, which is a surgical procedure to replace a damaged hip joint and restore its function. This therapeutic intervention directly addresses medical conditions like osteoarthritis, avascular necrosis, rheumatoid arthritis, and developmental hip dysplasia, aiming to alleviate symptoms and improve the patient's quality of life.
No
Explanation: The device is described as a "titanium femoral hip stem," which is an implant used in total hip arthroplasty, not a tool for diagnosing medical conditions. Its indications for use are for treatment of conditions like osteoarthritis and avascular necrosis, not for their diagnosis.
No
The device description clearly details a physical implant (femoral hip stem and modular femoral heads) made of titanium and other materials, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a total hip arthroplasty for treating various hip conditions. This is a surgical implant, not a device used to examine specimens derived from the human body.
- Device Description: The description details a femoral hip stem, a physical implant designed to be surgically placed in the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
Therefore, the MiniHip Stem is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The indications for the MiniHip Stem as a total hip arthroplasty include:
- · Non-inflammatory degenerative joint discase including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- · Correction of functional deformity
- · Development dysplasia of the hip (DDI-I) and congenital dysplasia of the hip (CDH)
The MiniHip Stem is indicated for cementless use only.
Product codes
LZO, MEH, KWL, OQI
Device Description
The MiniHip Stern is a titanium femoral hip stem featuring a 12/14 tapered male trumion for assembly with modular femoral head components. The MiniHip Stem uses a short stem philosophy to provide a bone-conserving option to the use of a standard total hip prosthesis. The stem is manufactured from Titanium (TiAI6V4) alloy and is proximally coated with plasma sprayed hydroxyapatite, conforming to ASTM F-1185-03(2009), over plasma sprayed purc titanium. The Corin MiniHip Stem is available in 7 sizes marked 3 through 9. The Corin MiniHip Stem was originally cleared in K083312 and K111046.
Modular CoCrMo Femoral Heads are available in a diameter of 28mm with -3.5mm (short), 0.0mm (standard) and, +3.5mm (long) offsets and diameter of 32mm, 36mm and 40mm heads with offsets of -4mm (short), 0mm (standard) and +4mm (long) as previously cleared in K093472 and K110087 submissions. The 32mm with +7mm offset (extra-long), and the 36mm and +0mm with +8mm offset (extra-long), were added to the range of heads available in K130343.
Modular BIOLOX detta™ Ceramic Femoral Heads are available in a diameter of 28mm with -3.5mm (short), 0mm (standard) and, +3.5mm (long) offsets and diameters of 32mm, 36mm and 40mm heads with offsets of -4mm (short), 0mm (standard) +4mm (long) as previously cleared in K103120 and K110087 submissions. The 32mm with +7mm offset (extra-long), and the 36mm and 40mm with +8mm offset (extra-long), were added to the range of heads available in K130343.
The Corin MiniHip Stem was originally cleared in K083312 and K111046 and as clearced compatible with short, standard and long offsets modular femoral heads. The purpose of this submission is to modify the labeling for the Corin MiniHip Stem to include an additional size of the compatible femoral heads. The addition is for three offsets in the CoCrMo and Ceramic extra-long heads, 32mm (+7mm), 36mm (+8mm) and 40mm (+8mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint / Femoral
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
Non-clinical testing conducted to demonstrate substantial equivalence includes a comparison of compatible components with the predicate devices. Clinical testing was not necessary to determine substantial equivalence between the Mini-hip Stem and the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K093472, K110087, K103120, K110087
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 16 2013
| 3. 510(K) SUMMARY | ||
|---|---|---|
| 1. Applicant/Sponsor: | Corin USA | |
| 5670 W. Cypress Street | ||
| Suite C | ||
| Tampa, Florida 33607 | ||
| Establishment Registration No.: 1056629 | ||
| 2. Contact Person: | Lucinda Gerber, BA (Hons) | |
| Regulatory Affairs Associate | ||
| Corin USA | ||
| 813-977-4469 | ||
| Lucinda.gerber@coringroup.com | ||
| 3. Date: | June 27, 2013 | |
| 4. Proprietary Name: | Corin Mini-Hip Stem | |
| 5. Common Name: | Hip Prosthesis | |
| 6. Product Codes: | LZO, MEH, KWL, OQI |
7. Classification Name:
- . Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21CFR 888.3353)
- . Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21CFR 888.3360)
8. Legally Marketed Devices to which Substantial Equivalence is claimed:
- Corin MiniHip Stem (K083312) .
- . Corin MiniHip Stem Size 3 (K111046)
- . Trinity Acetabular System with XL Heads (K130343)
9. Device Description:
The MiniHip Stern is a titanium femoral hip stem featuring a 12/14 tapered male trumion for assembly with modular femoral head components. The MiniHip Stem uses a short stem philosophy to provide a bone-conserving option to the use of a standard total hip prosthesis. The stem is manufactured from Titanium (TiAI6V4) alloy and is proximally coated with plasma sprayed hydroxyapatite, conforming to ASTM F-1185-03(2009), over plasma sprayed purc
1
titanium. The Corin MiniHip Stem is available in 7 sizes marked 3 through 9. The Corin MiniHip Stem was originally cleared in K083312 and K111046.
Modular CoCrMo Femoral Heads are available in a diameter of 28mm with -3.5mm (short), 0.0mm (standard) and, +3.5mm (long) offsets and diameter of 32mm, 36mm and 40mm heads with offsets of -4mm (short), 0mm (standard) and +4mm (long) as previously cleared in K093472 and K110087 submissions. The 32mm with +7mm offset (extra-long), and the 36mm and +0mm with +8mm offset (extra-long), were added to the range of heads available in K130343.
Modular BIOLOX detta™ Ceramic Femoral Heads are available in a diameter of 28mm with -3.5mm (short), 0mm (standard) and, +3.5mm (long) offsets and diameters of 32mm, 36mm and 40mm heads with offsets of -4mm (short), 0mm (standard) +4mm (long) as previously cleared in K103120 and K110087 submissions. The 32mm with +7mm offset (extra-long), and the 36mm and 40mm with +8mm offset (extra-long), were added to the range of heads available in K130343.
The Corin MiniHip Stem was originally cleared in K083312 and K111046 and as clearced compatible with short, standard and long offsets modular femoral heads. The purpose of this submission is to modify the labeling for the Corin MiniHip Stem to include an additional size of the compatible femoral heads. The addition is for three offsets in the CoCrMo and Ceramic extra-long heads, 32mm (+7mm), 36mm (+8mm) and 40mm (+8mm).
10. Intended Use / Indications:
The indications for the MiniHip Stem as a total hip arthroplasty include:
- · Non-inflammatory degenerative joint discase including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- · Correction of functional deformity
- · Development dysplasia of the hip (DDI-I) and congenital dysplasia of the hip (CDH)
The MiniHip Stem is indicated for cementless use only.
11. Summary of Technologies/Substantial Equivalence:
MiniHip Stems, subject of this submission, are identical to the predicate devices. 'This submission adds compatible modular femoral heads in an extra-long offset and is submitted for a modification of labeling. The additional compatible components of the Corin MiniHip Sicm,
2
K131986
subject device, are identical to predicate Trinity Acetabular System with XL Heads (K130343), compatible components, in terms of materials, intended use and indications and similar in design. Based on these similarities, Corin believes the MiniHip Stems, subject of this submission are substantially equivalent to the predicate devices.
12. Non-Clinical Testing:
Non-clinical testing conducted to demonstrate substantial equivalence includes a comparison of compatible components with the predicate devices.
13. Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the Minil-lip Stem and the predicate devices.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2013
Corin USA Lucinda Gerber, BA (Hons) Regulatory Affairs Associate 5670 West Cypress Street, Suite C Tampa, Florida 33607
Re: K131986 Trade/Device Name: MiniHip Stem 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, MEH, KWL, OOI Dated: November 7, 2013 Received: November 8, 2013
Dear Ms. Gerber:
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. 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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Lucinda Gerber. BA (Hons)
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 53.1-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours:
Ronald#19 Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE 2.
510(k) Number (if known): _K131986
Device Name: MiniHip Stem
Indications for Use:
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
- · Development dysplasia of the hip (DDH) and congenital dysplasia of the hip (CDH)
The MiniHip Stem is indicated for cementless use only.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Page __ of _1
Division of Orthopedic Devices