K Number

Device Name

Manufacturer

SULZER ORTHOPEDICS, INC.

Date Cleared

1997-12-19

(84 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

The Natural-Hip CoCr Offset Stern is intended for cemented use only in cases of hemi- or total hip replacement for treatment of the following:

Patient conditions of non-inflammatory 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 Description

The Natural-Hip CoCr Offset Stem is a collared straight stem manufactured from forged CoCr alloy (ASTM F799). The design provides 6-7mm of offset to allow the surgeon to more closely approximate the normal femoral head center in cases where varus deformity may be present. The proximal one-third of the stem's surface is grit blasted and features normalization steps which enhance cement compression and bonding for optimal fixation of the hip stem in the femoral canal. The distal portion of the stem has a hole to allow the use of a distal centralizer for correct distal alignment. The stem also employs proximal PMMA centralizers which, along with the distal centralizer, provide for an even cement mantle. The stem employs a Sulzer 12/14 configured neck trunnion for attachment to either a metallic, Biolox, or Zirconia femoral head having a Sulzer 12/14 configured bore

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Sulzer Orthopedics Inc. Natural-Hip CoCr Offset Stem." This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing de novo performance criteria through a clinical study with acceptance criteria, test sets, and ground truth.

Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within this document.

This type of 510(k) submission typically relies on:

Comparison of Technical Characteristics: Showing that the new device has similar materials, design, manufacturing processes, and intended use as already approved devices.
Performance Benchmarking (often non-clinical): This might involve mechanical testing, biocompatibility testing, or other engineering assessments to demonstrate that the new device performs as safely and effectively as the predicate devices, without directly involving patient data or clinical endpoints that would require the specific details you've asked for.

Here's a summary of what can be extracted from the provided text, and where the requested information is absent:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the format of pass/fail metrics for a clinical study. The "acceptance criteria" here implicitly revolve around demonstrating substantial equivalence to predicate devices in terms of design, materials, and intended use.
- Reported Device Performance: No quantitative performance metrics (e.g., accuracy, sensitivity, specificity, clinical outcome measures) are reported. The document describes the device's design features (e.g., offset, grit-blasted surface, centralizers) and its intended use, implying its performance is comparable to its predicates.
Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring ground truth is presented.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set is presented.
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 hip implant, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hip implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth for a clinical study is presented. The "ground truth" for this submission is demonstrating that the device is safe and effective because it is substantially equivalent to devices already on the market.
The sample size for the training set: Not applicable. No training set for an algorithm is presented.
How the ground truth for the training set was established: Not applicable. No training set or ground truth for a training set is presented.

Key Substantial Equivalence Information Provided:

Predicate Devices (Section {1}):
- Sulzer Orthopedics Natural-Hip CoCr Stem
- Howmedica Precision Strata Offset Stem
- Johnson & Johnson PFC Offset Stem
- DePuy Endurance Offset Stem
- DePuy Stability Offset Stem
- Osteonics Omnifit Enhanced Offset Stem
- The basis for acceptance is demonstrating substantial equivalence to these devices in terms of design, materials (forged CoCr alloy, ASTM F799), indications for use, and mechanical performance (implicitly, as it's a hip stem).

Summary

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

K9 7 368)

510(k) SUMMARY

DEC 1 9 1997

In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a 510(k) summary for the Sulzer Orthopedics Inc. Natural-Hip CoCr Offset Stem.

Submitter:	Sulzer Orthopedics Inc.9900 Spectrum DriveAustin, TX 78717(512)432-9900
Contact Person:	Jacquelyn HughesManager, Regulatory Affairs
Classification Name:	21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Common/Usual Name:	Femoral stem component for hip replacement
Trade/Proprietary Name:	Natural-Hip CoCr Offset Stem

PRODUCT DESCRIPTION:

SPECIFIC DIAGNOSTIC INDICATIONS:

The Natural-Hip CoCr Offset Stem is intended for cemented use only in cases of hemi- or total hip replacement for treatment of the following:

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

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

SUBSTANTIAL EQUIVALENCE:

Substantial equivalence determination is based on comparison of the Natural-Hip CoCr Offset Stem to the following legally marketed predicate competitive devices:

Sulzer Orthopedics Natural-Hip CoCr Stem ■
Howmedica Precision Strata Offset Stem 해
Johnson & Johnson PFC Offset Stem 트
DePuy Endurance Offset Stem
트 트 DePuy Stability Offset Stem
Osteonics Omnifit Enhanced Offset Stem 1

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC Ut 9 1997

Mitchell A. Dhority, RAC ·Senior Regulatory Affairs Specialist Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717

K973681 Re: Sulzer Orthopedics Natural-Hip Trade Name: CoCr Offset Stem Requlatory Class: II Product Code: LZO September 25, 1997 Dated: Received: September 26, 1997

Dear Mr. Dhority:

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 aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ದ 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 requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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 requlations.

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

Page 2 - Mitchell A. Dhority, RAC

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 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
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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):

Device Name: Sulzer Orthopedics Natural-Hip CoCr Offset Stem _________________________________________________________________________________________________________________

Indications for Use:

The Natural-Hip CoCr Offset Stern is intended for cemented use only in cases of hemi- or total hip replacement for treatment of the following:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off)
	Division of General Restorative Devices
510(k) Number	K973681
Prescription Use	X
	OR
Over-the Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

N/A