DEPUY C-STEM SYSTEM

K982918 · DePuy Orthopaedics, Inc. · JDI · Oct 5, 1998 · Orthopedic

Device Facts

• Record ID: K982918
• Device Name: DEPUY C-STEM SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Oct 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy C-Stem System is indicated for cemented use as the femoral component in total hip arthroplasty for replacing the hip joint of a patient with a severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement; and certain cases of ankylosis.

Device Story

DePuy C-Stem System is a cemented femoral hip prosthesis; includes stainless steel femoral stems, gelatin end caps, and PMMA centralizers. Stem design is collarless, slim-profiled, triple-tapered, and polished. Available in four configurations: CDH, primary, high offset, and revision. Used by orthopedic surgeons in total hip arthroplasty procedures to replace painful or disabled hip joints. Device functions as a structural implant to restore joint function and reduce pain. Substantially equivalent to existing hip systems based on shared materials (Ortron stainless steel), design features (collarless, polished), and intended use in cemented arthroplasty.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use similarities to legally marketed predicate devices.

Technological Characteristics

Materials: Ortron stainless steel, PMMA (centralizers), gelatin (end caps). Design: Collarless, slim-profiled, triple-tapered, polished femoral stems. Modular heads. Includes femoral canal centering devices (end caps, centralizers). Cemented fixation.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to osteoarthritis, traumatic/rheumatoid arthritis, avascular necrosis, acute traumatic fracture of femoral head/neck, failed previous hip surgeries (reconstruction, fixation, arthrodesis, hemiarthroplasty, surface replacement, total hip replacement), or ankylosis.

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

• CPT Hip Prosthesis (K960658)
• Exeter Total Hip System (K974054, K980843)
• Ortron 90 Hip Prosthesis (Charnley) (K802627)
• DePuy Elite Hip (K871867)
• BIOSTOP G Bone Cement Restrictor (K943727)
• DePuy Distal Stem Centralizers (K951930)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string starts with a capital letter 'K' that has a diagonal line through it. Following the 'K' are the numbers '982918', written in a cursive style.

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| SPONSOR OF THIS 510(K): | DePuy, Inc.<br>P.O. Box 988<br>Warsaw, Indiana 46581-0988 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Sally Foust<br>DePuy Orthopaedics, Inc.<br>Sr. Regulatory Submissions Associate<br>[phone]; FAX [phone] |
| TRADE NAME: | DePuy C-Stem™ System |
| COMMON NAME: | Hip prosthesis |
| CLASSIFICATION: | Class II per 888.3350, Hip joint metal/polymer semi-<br>constrained cemented prosthesis |
| DEVICE CODE: | JDI |
| EQUIVALENT DEVICES: | CPT Hip Prosthesis (K960658)<br>Exeter Total Hip System (K974054, K980843)<br>Ortron 90* Hip Prosthesis (Charnely) (K802627)<br>DePuy Elite Hip (K871867)<br>BIOSTOP® G Bone Cement Restrictor (K943727)<br>DePuy Distal Stem Centralizers (K951930) |

## DEVICE DESCRIPTION AND INTENDED USE:

The subject DePuy C-Stem System includes stainless steel femoral stems, a gelatin end cap and PMMA centralizers. The C-Stern is a collarless, slim profiled, triple-tapered, and overall polished stem that is available in four stem designs. The four stem designs are: a CDH stem available in one size; a primary stem available in eight sizes (1, 2, 3, 4, 5, 6, 7; an d 8); a high offset stem available in three sizes (3, 4, and 5); and a revision stem available in three sizes (4, 6, and 8) each of which is available in two lengths (200mm and 240mm).

The DePuy C-Stem System is indicated for cemented use as the femoral component in total hip arthroplasty for replacing the hip joint of a veinent with a severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis; avasular necrosis of the femoral head; acute transatic facture of the femoral head or neck; failed previous surgery, including joint reconstruction, internal fixation nead of neeks, laned previous surgery, surface replacement arthroplasty, or other total hip replacement, and certain cases of ankylosis.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The subject C-Stem System is identical in material and intended use to the FDA cleared Elite and Chanley hip stems in that the stems are manufactured from Ortron stainless steel and are intended

{1}------------------------------------------------

for cemented use as the femoral component in total hip arthroplasty. The subject C-Stem System is similar in material, design, and intended use to the FDA cleared Exeter Total Hip System in that the stems are manufactured from stainless steel, collarless, slim profiled, polished, and are intended for cemented use as the femoral component in total hip arthroplasty in which femoral canal centering devices are used (i.e., end caps, centralizers). The subject C-Stem System is similar in design and intended use to the FDA cleared CPT Hip Prosthesis in that the stems are collarless, slim-profiled, polished and are intended for cemented use as the femoral component in total hip arthroplasty in which femoral canal centering devices are used. All materials used to manufacture the subject C-Stem System's components (stems, end cap, and centralizers) are also those used to manufacture the referenced FDA cleared orthopaedic devices.

Based on similarities of design, materials and intended use, DePuy believes that the subject C-Stem System is substantially equivalent to the FDA cleared CPT, Exeter, Elite and Charnley Hip Systems.

| | C-STEM | CPT | EXETER | ELITE | CHARNLEY |
|----------------------------------------------------|--------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|
| Material | Ortron<br>Stainless<br>Steel | Cobalt-<br>Chrome | 316L<br>Stainless<br>Steel | Ortron<br>Stainless<br>Steel | Ortron<br>Stainless Steel |
| Use | Cemented | Cemented | Cemented | Cemented | Cemented |
| Design | Collarless<br>Slim Profile<br>Three Tapers<br>Polished | Collarless<br>Slim Profile<br>Two Tapers<br>Polished | Collarless<br>Slim Profile<br>Two Tapers<br>Polished | Collarless<br>Slim Profile<br>Two Tapers<br>Textured | Collarless<br>Slim Profile<br>Two-Tapers<br>Textured |
| Modular Heads | Yes | Yes | Yes | Yes | No |
| EndCaps/<br>Centralizers/<br>Cement<br>Restrictors | Yes | Yes | Yes | Yes | Yes |

The following table summarizes the similarities:

{2}------------------------------------------------

Image /page/2/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 with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 OCT

Ms. Sally Foust Senior Regulatory Submissions Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

K982918 Re : DePuy C-Stem™ System Trade Name: Regulatory Class: -II Product Codes: JDI, LZO, and LZN Dated: August 18, 1998 Received: Auqust 19, 1998

Dear Ms. Foust:

We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. ਮ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

{3}------------------------------------------------

Page 2 - Ms. Sally Foust

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results of your device to a legally
device and thus, pormits woundits 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594–4659. 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
premation entification" (21 CPR 807.97) . Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollefone one of one of Manufacturers Assistance
its internet addrose Ubters [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html",

Sincerely yours,

Celia M. Witten, Ph.D.

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

Enclosure

{4}------------------------------------------------

## 510(k) Number (if known) K982 918

Device Name: DePuy C-Stem™ System

Indications for Use:

The DePuy C-Stem System is indicated for cemented use as the femoral component in total hip arthroplasty for replacing the hip joint of a patient with a severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement; and certain cases of ankylosis.

Concurrence of CDRH, Office of Device Evaluation

Prescription Use ... X (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

7

Division Sign Off

Sign-Off f General Restorative Devices Division 982918 510(k) Number

00002