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 Porous Stem with Offset is intended for use 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 Porous Stem with Offset is a straight stem available in both a collared and collarless design. The design of the neck/taper region 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 component is manufactured from forged titanium alloy (Ti-6AL-The proximal surface of the stem employs circumferential CSTi porous 4V. ASTM F620). coating to provide biological fixation which reduces tracks of debris, thereby potentially inhibiting osteolysis. The collared stem employs CSTi porous coating on the inferior surface of the collar to prevent calcar resorption by providing biological fixation and load transfer in cementless applications. The proximal anterior surface of the stem employs anterior angulation or build-up to match the anatomic angulation of a natural femur. The superior portion has a built-in anteversion of nine degrees (90) to match the anatomic anteversion of the femur. Due to this feature, separate left and right components are offered. The distal portion of the stem employs ribs and flutes on the anterior and posterior sides to enhance cortical contact, thereby providing rotational stability to the stem. In addition, the distal portion of the stem has a flared coronal slot which reduces stem stiffness. The slot provides optimal distal fill of the femoral canal for additional rotational stability. A Sulzer 12/14 configured neck trunnion allows for attachment to a metallic, Biolox, or Zirconia femoral head having a Sulzer 12/14 configured bore

AI/ML Overview

This document is a 510(k) summary for a medical device (Sulzer Orthopedics Inc. Natural-Hip Porous Stem with Offset), not a study report. Therefore, it does not contain the detailed information about acceptance criteria and study results you are asking for.

Here's why the requested information cannot be found in the provided text:

Acceptance Criteria and Reported Device Performance: This document states the indications for use of the device and identifies predicate devices for substantial equivalence. It does not list specific performance criteria (e.g., strength, durability, wear rates) or provide data on how the Natural-Hip Porous Stem with Offset performed against those criteria. Substantial equivalence for this type of device typically relies on demonstrating that the new device has the same technological characteristics and intended use as legally marketed predicate devices, implying similar performance.
Sample Size and Data Provenance: No clinical study data is presented, so there's no mention of sample sizes for test sets or data provenance (country of origin, retrospective/prospective).
Number/Qualifications of Experts for Ground Truth: Since no study with a ground truth component is described, there's no information about experts or their qualifications.
Adjudication Method: Not applicable as no study requiring adjudication is referenced.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study is relevant for diagnostic devices where human readers interpret results. The Natural-Hip Porous Stem is an orthopedic implant, so MRMC studies are not applicable.
Standalone Performance: Not applicable for an orthopedic implant. Standalone performance relates to the accuracy of an algorithm without human intervention, which isn't considered for a physical medical device like a hip stem.
Type of Ground Truth Used: Not applicable, as there's no diagnostic study involving ground truth determination.
Sample Size for Training Set: No training set is mentioned as this is not a machine learning/AI device.
How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document is a regulatory submission for premarket clearance (510(k)) based on substantial equivalence, not a clinical trial report detailing performance data against specific acceptance criteria. Such a submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by showing similar design, materials, and intended use, rather than presenting novel performance study data.

Summary

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K973675

DEC 19 1997 510(k) SUMMARY

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 Porous Stem with Offset.

Submitter:	Sulzer Orthopedics Inc.9900 Spectrum DriveAustin, TX 78717(512)432-9900
Contact Person:	Jacquelyn HughesManager, Regulatory Affairs
Classification Name:	21 CFR 888.3358 - Hip joint metal/polymer/metal porousuncemented prosthesis
Common/Usual Name:	Femoral stem component for hip replacement
Trade/Proprietary Name:	Natural-Hip Porous Stem with Offset

PRODUCT DESCRIPTION:

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SPECIFIC DIAGNOSTIC INDICATIONS:

The Natural-Hip Porous Stem with Offset is intended for use 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.

SUBSTANTIAL EQUIVALENCE:

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

Sulzer Orthopedics Natural-Hip Porous Stem 동
트 Howmedica Precision Strata Offset Stem
Johnson & Johnson PFC Offset Stem
를 투 DePuy Endurance Offset Stem
I DePuy Stability Offset Stem
Osteonics Omnifit Enhanced Offset Stem

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. The text is written in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 19 1997

Ms. Jacquelyn Hughes Manager, Requlatory Affairs Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717

Re: K973675 Trade Name: Sulzer Orthopedics Natural-Hip Porous Stem with Offset Requlatory Class: II Product Code: LPH Dated: September 25, 1997 September 26, 1997 Received:

Dear Ms. Hughes:

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. ਸ 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 regulatory 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. Jacquelyn Hughes

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 ene regaración Chorosos, "21255 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,

Ph.D., M.D. Cella M. Witten, 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):_____________________________________________________________________________________________________________________________________________________

Device Name: _Sulzer Orthopedics Natural-Hip Porous Stem with Offset

Indications for Use:

The Natural-Hip Porous Stem with Offset is intended for use 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

Prescription Use	X
510(k) Number	K973675

Over-the Counter Use
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(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.