(122 days)
The indications for the Corin Metafix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a 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) and congenital dysplasia of the hip (CDH)
The Corin Metafix Hip Stem is indicated for cementless use only.
The Corin Metafix Hip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from Titanium (TiAL6V4) alloy for surgical implant applications, conforming to ASTM F136-11 and is coated with plasma sprayed hydroxyapatic conforming to ASTM F-1185-03(2009). The stem is currently available in nine sizes (2-10), each available in three offsets including Standard (1359), Lateralized 135°, and Standard (125°).
The Corin Metalix Hip Stem was originally cleared in K082525. This submission is for one additional stem size, size 1 in two available offsets, Standard (1359 and Lateralized 135°. Like the originally cleared Metafix Stems, the additional stem size features a low profile lateral shoulder, a tapered metaphyseal flare as well as a vertically and horizontally grooved stem, providing for rotational and axial stability.
The indications and compatible components for use with the Corin Metafix size 1 are identical to that of the predicate devices (K082525 & K120362).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Corin Metafix Hip Stem:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical fatigue testing of neck and stem (safe and effective) | "The results of this testing show that the Corin Metafix Hip size 1 Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device." |
| Substantial equivalence to predicate device (K082525, K120362) | Claimed and supported by non-clinical testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The non-clinical testing section only mentions "mechanical fatigue testing of the neck and stem" without specifying the number of samples or units tested.
- Data Provenance: Not explicitly stated. The nature of the testing (mechanical fatigue) suggests laboratory-based testing rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. This study involved non-clinical mechanical testing, not a diagnostic or prediction study requiring expert-established ground truth from images or clinical assessments.
4. Adjudication Method for the Test Set
- Not applicable. This study involved non-clinical mechanical testing, not a diagnostic or prediction study requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No. This is a submission for a hip stem, a medical device, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- No. As mentioned above, this is for a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is based on mechanical test standards and engineering principles. The device's ability to withstand specified loads and cycles (fatigue testing) according to ASTM standards (F136-11, F-1185-03(2009)) serves as the basis for determining its safety and effectiveness.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for a machine learning model, this question is irrelevant.
Summary of the Study:
The study described is a non-clinical engineering evaluation to demonstrate the substantial equivalence of an additional size (size 1) of the Corin Metafix Hip Stem to previously cleared predicate devices. The primary method of proof relies on mechanical fatigue testing of the neck and stem. The results of this testing are expected to show that the new size is safe and effective for its proposed indications and design compared to the predicate devices. No clinical testing, human-reader studies, or AI-related evaluations were deemed necessary for this submission. The "ground truth" for this type of device is adherence to recognized mechanical testing standards and performance comparable to legally marketed predicates.
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K121439
PAGE 1 OF 3
..
| 3. | 510(K) SUMMARY |
|---|---|
| 1. Applicant/Sponsor: | Corin USA |
| 10500 University Center Drive | |
| Suite 190 | |
| Tampa, Florida 33612 | |
| 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: | May 14, 2012 |
| 4. Proprietary Name: | Corin Metafix Hip Stem |
| 5. Common Name: | Hip Prosthesis |
| 6. Product Codes: | LZO, KWL, KWY, JDI |
| 7. Classification Name: | Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21CFR 888.3390) |
| Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21CFR 888.3360) | |
| Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21CFR 888.3353) | |
| Hip joint metal/polymer semi-constrained cemented prosthesis. (21CFR 888.3350) | |
| 8. Legally Marketed Devices to which Substantial Equivalence is claimed: | |
| Corin Metafix Hip Stem (K082525) | |
| Corin Metafix Hip Stem with Hemi-Arthroplasty (K120362) |
{1}------------------------------------------------
ાં મુક્તિયું તે તે જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આં op 2 ામ જ દિલ્
· 9. Device Description:
The Corin Metafix Hip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from Titanium (TiAL6V4) alloy for surgical implant applications, conforming to ASTM F136-11 and is coated with plasma sprayed hydroxyapatic conforming to ASTM F-1185-03(2009). The stem is currently available in nine sizes (2-10), each available in three offsets including Standard (1359), Lateralized 135°, and Standard (125°).
The Corin Metalix Hip Stem was originally cleared in K082525. This submission is for one additional stem size, size 1 in two available offsets, Standard (1359 and Lateralized 135°. Like the originally cleared Metafix Stems, the additional stem size features a low profile lateral shoulder, a tapered metaphyseal flare as well as a vertically and horizontally grooved stem, providing for rotational and axial stability.
The indications and compatible components for use with the Corin Metafix size 1 are identical to that of the predicate devices (K082525 & K120362).
10. Intended Use / Indications:
The indications for the Corin Metafix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hem-arthroplasty femoral heads, as a 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 Corin Metafix Hip Stem is intended for cementless use only.
11. Summary of Technologies/Substantial Equivalence:
The additional component of the Corin Metafix Hip Stem is similar to the predicate Corin Metafix Hip Stems in terms of design, and is identical in materials, intended use and indications. Based on these similarities, Corin believes that the Mctafix Hip Stem is substantially equivalent to the predicate devices.
{2}------------------------------------------------
PAGE 3 OF 3
12. Non-Clinical Testing:
Non-clinical testing and analysis included mechanical fatigue testing of the neck and stem. The results of this testing show that the Corin Mctafix Hip size 1 Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.
13. Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the additional size of the Corin Metafix Hip Stem and the predicate device.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure in blue, with three heads or faces suggesting a sense of community or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Corin U.S.A. % Ms. Lucinda Gerber 10500 University Center Drive Suite 190 Tampa. FL 33612
SEP 1 9 2012
Re: K121439
Trade/Device Name: Metafix Femoral Hip Stem Size 1 Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis
Regulatory Class: II Product Code: LZO, KWL, KWL, KWY Dated: September 7, 2012 Received: September 10, 2012
Dear Ms. Gerber:
This letter corrects our substantially equivalent letter of September 14. 2012.
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 (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.
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
{4}------------------------------------------------
Page 2 - Ms. Lucinda Gerber
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
2. INDICATIONS FOR USE
| 510(k) Number (if known): | K121439 |
|---|---|
| --------------------------- | --------- |
Device Name: Corin Metafix I-lip Stem
Indications for Use:
The indications for the Corin Metafix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:
- o Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis o
- Correction of functional deformity 0
- Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur 0
- Developmental dysplasia of the hip (DDH) and congenital dysplasia of the hip (CDH) O
The Corin Metafix Hip Stem is indicated for cementless use only.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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) | |
|---|---|
| -------------------------------------------------------- | -- |
ASRB
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | K121439 |
|---|---|
| --------------- | --------- |
{6}------------------------------------------------
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§ 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.