DEPUY C-STEM SYSTEM by DEPUY ORTHOPAEDICS, INC.

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 Description

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).

AI/ML Overview

This document is a 510(k) summary for the DePuy C-Stem™ System, a hip prosthesis. It is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Critical Note: This 510(k) summary does not contain acceptance criteria for device performance, nor details of a study that proves the device meets such criteria. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through comparisons of design, materials, and intended use, rather than presenting clinical trial data or performance against acceptance thresholds.

Therefore, many of the requested information points cannot be provided from the given text.

Here's a breakdown of what can be extracted or inferred based on the document's nature:

1. A table of acceptance criteria and the reported device performance

Not applicable. This document does not define explicit acceptance criteria for device performance (e.g., mechanical strength, wear rates, clinical outcomes) for the DePuy C-Stem™ System itself. Instead, it argues that the device's design, materials, and intended use are similar to already approved devices. There is no "reported device performance" against specific acceptance criteria presented here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe performance testing or clinical studies with test sets in the way implied by this question. It relies on a comparison with predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No expert-established ground truth for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical hip prosthesis, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. No ground truth for performance testing is discussed. The "ground truth" for the submission is the regulatory acceptance of the predicate devices.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an algorithm that uses training data.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device, not an algorithm that uses training data.

Summary of available information from the document (relevant to substantial equivalence, not performance criteria):

The basis of substantial equivalence is a comparison of the DePuy C-Stem™ System to several FDA-cleared 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), and DePuy Distal Stem Centralizers (K951930).

The argument for substantial equivalence is based on:

Material: Ortron Stainless Steel (similar to Elite and Charnley), or stainless steel (similar to Exeter).
Intended Use: Cemented use as the femoral component in total hip arthroplasty (identical to all predicates mentioned).
Design: Collarless, slim profiled, polished, use of femoral canal centering devices (similar to CPT and Exeter). The C-Stem has three tapers, while CPT and Exeter have two; Elite and Charnley are textured rather than polished, but are otherwise similar.
Component usage: Modular heads, end caps/centralizers/cement restrictors (present in C-Stem and most predicates).

The document explicitly states: "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."

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

SPONSOR OF THIS 510(K):	DePuy, Inc.P.O. Box 988Warsaw, Indiana 46581-0988
510(K) CONTACT:	Sally FoustDePuy Orthopaedics, Inc.Sr. Regulatory Submissions Associate(219) 372-7455; FAX (219) 267-7098
TRADE NAME:	DePuy C-Stem™ System
COMMON NAME:	Hip prosthesis
CLASSIFICATION:	Class II per 888.3350, Hip joint metal/polymer semi-constrained cemented prosthesis
DEVICE CODE:	JDI
EQUIVALENT DEVICES:	CPT Hip Prosthesis (K960658)Exeter Total Hip System (K974054, K980843)Ortron 90* Hip Prosthesis (Charnely) (K802627)DePuy Elite Hip (K871867)BIOSTOP® G Bone Cement Restrictor (K943727)DePuy Distal Stem Centralizers (K951930)

DEVICE DESCRIPTION AND 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 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

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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	OrtronStainlessSteel	Cobalt-Chrome	316LStainlessSteel	OrtronStainlessSteel	OrtronStainless Steel
Use	Cemented	Cemented	Cemented	Cemented	Cemented
Design	CollarlessSlim ProfileThree TapersPolished	CollarlessSlim ProfileTwo TapersPolished	CollarlessSlim ProfileTwo TapersPolished	CollarlessSlim ProfileTwo TapersTextured	CollarlessSlim ProfileTwo-TapersTextured
Modular Heads	Yes	Yes	Yes	Yes	No
EndCaps/Centralizers/CementRestrictors	Yes	Yes	Yes	Yes	Yes

The following table summarizes the similarities:

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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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 .

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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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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510(k) Number (if known) K982 918

Device Name: DePuy C-Stem™ System

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation

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

Over-The-Counter Use_

Division Sign Off

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

00002

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
Classification. Class II.