Predicate Devices

K960658, K974054, K980843, K802627, K871867, K943727, K951930

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical implant (femoral stem) and associated components, with no mention of software, algorithms, or data processing that would indicate AI/ML technology.

Therapeutic

Yes.
The device, a femoral component for total hip arthroplasty, is used to replace a damaged hip joint and restore function, which directly alleviates pain and disability, fitting the definition of a therapeutic intervention.

Diagnostic

No

The device description indicates it is a component of a total hip arthroplasty, and its intended use is to replace a hip joint. This is a therapeutic device, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the DePuy C-Stem System includes physical components such as stainless steel femoral stems, a gelatin end cap, and PMMA centralizers. This indicates it is a hardware-based medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a surgical implant for replacing a hip joint. This is a therapeutic device used in vivo (within the body).
Device Description: The description details physical components like femoral stems, an end cap, and centralizers, which are all parts of a surgical implant.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is a surgical implant used in vivo.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

JDI, LZO, LZN

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip joint

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K960658, K974054, K980843, K802627, K871867, K943727, K951930

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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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.
P.O. Box 988
Warsaw, Indiana 46581-0988 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Sally Foust
DePuy 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 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

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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	Ortron
Stainless
Steel	Cobalt-
Chrome	316L
Stainless
Steel	Ortron
Stainless
Steel	Ortron
Stainless Steel
Use	Cemented	Cemented	Cemented	Cemented	Cemented
Design	Collarless
Slim Profile
Three Tapers
Polished	Collarless
Slim Profile
Two Tapers
Polished	Collarless
Slim Profile
Two Tapers
Polished	Collarless
Slim Profile
Two Tapers
Textured	Collarless
Slim Profile
Two-Tapers
Textured
Modular Heads	Yes	Yes	Yes	Yes	No
EndCaps/
Centralizers/
Cement
Restrictors	Yes	Yes	Yes	Yes	Yes

The following table summarizes the similarities:

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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

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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:

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_

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Division Sign Off

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

00002