METAFIX FEMORAL HIP STEM SIZE 1

K121439 · Corin USA · LZO · Sep 14, 2012 · Orthopedic

Device Facts

• Record ID: K121439
• Device Name: METAFIX FEMORAL HIP STEM SIZE 1
• Applicant: Corin USA
• Product Code: LZO · Orthopedic
• Decision Date: Sep 14, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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: - 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.

Device Story

The Corin Metafix Hip Stem is a titanium alloy (Ti6Al4V) femoral hip implant designed for cementless fixation. It features a 12/14 tapered male trunnion for modular femoral head assembly and a plasma-sprayed hydroxyapatite coating to promote osseointegration. The stem includes a low-profile lateral shoulder, a tapered metaphyseal flare, and vertical/horizontal grooves to enhance rotational and axial stability. It is available in multiple sizes and offsets. The device is implanted by orthopedic surgeons during hip arthroplasty procedures in hospital or surgical center settings. The surgeon selects the appropriate size and offset based on patient anatomy to restore joint function and stability. The device provides a structural foundation for the hip joint, aiming to alleviate pain and improve mobility in patients with degenerative or traumatic hip conditions.

Clinical Evidence

No clinical data was provided. Substantial equivalence was determined based on bench testing, specifically mechanical fatigue testing of the neck and stem.

Technological Characteristics

Material: Titanium alloy (Ti6Al4V) per ASTM F136-11. Coating: Plasma-sprayed hydroxyapatite per ASTM F1185-03(2009). Design: Femoral hip stem with 12/14 tapered male trunnion, metaphyseal flare, and surface grooves. Fixation: Cementless. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring total or hemi-hip arthroplasty due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, non-union, femoral neck/trochanteric fractures, or hip dysplasia (DDH/CDH). For cementless use only.

Regulatory Classification

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.

Predicate Devices

• Corin Metafix Hip Stem (K082525)
• Corin Metafix Hip Stem with Hemi-Arthroplasty (K120362)

Submission Summary (Full Text)

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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 |
| | [e-mail] |
| 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) |

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#### · 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.

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# 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.

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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

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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 [phone] or [phone] 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

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#### 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 |
|---------------|---------|
|---------------|---------|

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