DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS

K023453 · DePuy Orthopaedics, Inc. · JDI · Nov 13, 2002 · Orthopedic

Device Facts

• Record ID: K023453
• Device Name: DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Nov 13, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: - A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia; - Avascular necrosis of the femoral head; - Acute traumatic fracture of the femoral head or neck; - Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement; - Certain cases of ankylosis. The Summit FX Cemented Hip Stem is intended for cemented use only.

Device Story

Summit FX Cemented Hip Stem is a flanged, collared, tapered Cobalt-Chromium femoral stem with smooth surface finish; used in total hip arthroplasty to replace damaged hip joint articulation; intended for cemented use only; features distal PMMA centralizer to ensure stem centering in femoral canal; offered in 7 sizes with constant offset; used by orthopedic surgeons in clinical settings; provides patient mobility and pain reduction; device design is a variation of the predicate Summit Cemented Hip Stem, specifically optimized for femoral head and neck fractures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material similarity to the predicate device.

Technological Characteristics

Material: Cobalt-Chromium alloy. Design: Flanged, collared, tapered femoral stem with smooth surface finish. Features: Distal PMMA centralizer. Configuration: 7 sizes, constant offset. Intended for cemented use only.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery (reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement, or total hip replacement), or ankylosis, provided there is sufficient sound bone to seat and support components.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• DePuy Summit Cemented Hip Prosthesis (K013352)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, IN 46581-0988 |
|----------------------------------|-----------------------------------------------------------------------------------|
| 510(k) CONTACT: | Cheryl Hastings Director, Regulatory Affairs |
| TRADE NAME: | DePuy Summit FX Cemented Hip Prosthesis |
| COMMON NAME: | Total Hip Joint Replacement Prosthesis |
| CLASSIFICATION: | 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis; Class II |
| DEVICE PRODUCT CODE: | 87 JDI |
| SUBSTANTIALLY EQUIVALENT DEVICE: | DePuy Summit Cemented Hip Prosthesis, K013352 |

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## DEVICE DESCRIPTION:

The Summit FX Cemented Hip Stem is a flanged, collared, tapered Cobalt-Chromium femoral stem with a smooth surface finish. The Summit FX Cemented Hip Stem is offered in 7 sizes with a constant offset. A distal PMMA centralizer helps assure that the stem is centered in the femoral canal. The stem is designed specifically to treat femoral head and neck fractures but can be used for any of the indications listed below.

## INTENDED USE AND INDICATIONS:

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid ● arthritis, or congenital hip dysplasia;
- Avascular necrosis of the femoral head; ●
- Acute traumatic fracture of the femoral head or neck; ●
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, ● hemiarthroplasty, surface replacement arthroplasty, or total hip replacement;
- Certain cases of ankylosis. ●

The Summit FX Cemented Hip Stem is intended for cemented use only.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The Summit FX Cemented Hip Stem is manufactured from the same material and has the same intended use as the Summit Cemented Hip Stem. The designs are similar, but the Summit FX Cemented Hip Stem is offered in only one offset and has no proximal centralizer beads. The Summit Cemented Hip Stem is offered in two offsets and includes proximal centralizer beads.

# 0000003

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them. The logo is black and white.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Cheryl Hastings Director. Regulatory Affairs DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 4681-0988

Re: K023453

Trade Name: Summit FX Cemented Hip Stems Regulation Number: 21 CRF 888.3350 Regulation Name: Hip Joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI Dated: October 11, 2002 Received: October 15, 2002

Dear Ms. Hastings:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 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.

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Page 2 - Ms. Cheryl Hastings

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Mark A. Milluzzo

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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02) 34.5 510(k) Number (if known)

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Device Name DePuy Summit FX Cemented Hip Stem

Intended Use and Indications:

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components.

Total hip replacement is indicated in the following conditions:

- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid ● arthritis, or congenital hip dysplasia;
- Avascular necrosis of the femoral head; ●
- Acute traumatic fracture of the femoral head or neck;
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, ● hemiarthroplasty, surface replacement arthroplasty, or total hip replacement;
- Certain cases of ankylosis.

The Summit FX Cemented Hip Stem is intended for cemented use only.

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Concurrence of CDRH, Office of Device Evaluation

Mark N. Milken

(Division Sign-Off) Division of General, Restorative and Neurological Devices 023453

510(k) Number -

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use

0000004