CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP

K032348 · Centerpulse Orthopedics, Inc. · LZO · Oct 24, 2003 · Orthopedic

Device Facts

• Record ID: K032348
• Device Name: CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP
• Applicant: Centerpulse Orthopedics, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Oct 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Converge RETi-Lock Multi-Hole Reinforcement Cup is intended for use in total hip arthroplasty for treatment of the following: - Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - Those patients with failed previous surgery where pain, deformity, or dysfunction persists. - Revision of previously failed hip arthroplasty.

Device Story

Converge RETi-Lock Multi-Hole Reinforcement Cup is a hemispherical acetabular reinforcement shell; constructed from titanium alloy. Designed for total hip arthroplasty in patients with deficient acetabular bone stock. Features include fixation plate contoured to ilium; hook for obturator foramen attachment; multiple screw holes for fixation in remaining bone stock. Used by orthopedic surgeons in clinical/surgical settings. Provides mechanical reinforcement and stability to acetabular component; facilitates fixation in compromised bone; aids in revision or complex primary arthroplasty cases.

Clinical Evidence

No clinical data; substantial equivalence based on bench testing, design comparisons, and functional analyses.

Technological Characteristics

Hemispherical acetabular reinforcement shell; titanium alloy construction; features fixation plate and obturator hook; multi-hole design for screw fixation; non-porous press-fit system.

Indications for Use

Indicated for patients undergoing total hip arthroplasty suffering from noninflammatory degenerative joint disease (e.g., avascular necrosis, osteoarthritis), inflammatory joint disease (e.g., rheumatoid arthritis), failed previous surgery with persistent pain/deformity/dysfunction, or requiring revision of failed hip arthroplasty.

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

• Ascendant Acetabular System (K022985)
• Restoration GAP II Cup (K980774)

Submission Summary (Full Text)

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000049

K032348

OCT 2 4 2003

# 510(k) SUMMARY

| SPONSOR NAME: | Centerpulse Orthopedics, Inc.<br>9900 Spectrum Drive<br>Austin, TX 78717 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Robert M. Wolfarth<br>Phone: [phone]<br>E-Mail: [e-mail] |
| TRADE NAME: | Converge RETi-Lock Multi-Hole Reinforcement Cup |
| COMMON NAME: | Non-porous, press-fit, acetabular shell system |
| CLASSIFICATION: | Non-porous, press-fit, acetabular shell systems (Product Codes 87<br>LZO, KWA, JDI, LWJ) are Class II per 21 CFR §§888.3353, .3330,<br>and .3350 respectively, reviewed by the Orthopedic Devices panel. |

#### PREDICATE DEVICES:

- Ascendant Acetabular System (K022985) ●
- Restoration GAP II Cup (K980774) .

## DEVICE DESCRIPTION:

The Converge RETi-Lock Multi-Hole Reinforcement Cup is a hemispherical acetabular reinforcement shell made of titanium alloy. It is designed to expand the surgeon's options for treatment in cases when acetabular bone stock is deficient. This device also has a fixation plate designed to match the contour of the ilium of the acetabulum and a hook designed to attach to the obturator foramen. Numerous screw holes in the cup and along the plate help to ensure fixation in good bone stock.

### INTENDED USE:

The Converge RETi-Lock Multi-Hole Reinforcement Cup is intended for use in total hip arthroplasty for treatment of the following:

- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- . Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- . Revision of previously failed hip arthroplasty.

### BASIS OF SUBSTANTIAL EQUIVALENCE:

Performance testing, design comparisons, and functional analyses conducted on the Converge RETi-Lock Multi-Hole Reinforcement Cup demonstrate that this device is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2003

Mr. Robert M. Wolfarth Regulatory Affairs Programs Manager Centerpulse Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717

Re: K032348

Trade/Device Name: Converge RETi-Lock Multi-Hole Reinforcement Cup Regulation Numbers: 21 CFR 888.3353; 21 CFR 888.3330; 21 CFR 888.3350 Regulation Names: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis; Hip joint metal/metal semiconstrained, with an uncemented acetabular component, prosthesis; Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II, III, II Product Codes: LZO, KWA, JDI, LWJ Dated: July 29, 2003 Received: July 31, 2003

Dear Mr. Wolfarth:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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#### Page 2 - Mr. Robert M. Wolfarth

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Sincerely, yours,

Mark A. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications For Use

## 510(K) Number:

K032348

Device Name:

Converge RETi-Lock Multi-Hole Reinforcement Cup

#### Indications for Use:

The Converge RETi-Lock Multi-Hole Reinforcement Cup is intended for use in total hip arthroplasty for treatment of the following:

- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis;
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists; ●
- . Revision of previously failed hip arthroplasty.

#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ***_*** OR Over-The-Counter Use **_**
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

for Mark n Melleur
(Division Sign-Off)
ion of General, Restorative
Neurological Devices
K032348