The UNI-ROM™ Total Hip Stem is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.

Device Description

The UNI-ROM™ Femoral Hip Stem is a one-piece porous coated hip stem that manufactured from titanium alloy (Ti-6Al-4V). The stem is designed with steps on the outer surface of the porous-coated area to encourage compressive loading of the bone there by allowing for uncemented fixation. The proximal circumferential area is porous coated with commercially pure titanium. The UNI-ROM™ Femoral Hip Stem is anatomically shaped with flutes and a coronal slot in the distal portion of the stem. The UNI-ROM™ Femoral hip stem can be used in either the right or left hip and mates with the femoral hip head using an 11/13 Morse-type taper. Further, the femoral stem is designed to accept an S-ROM Co-Cr Femoral head or an S-ROM Ceramic Femoral Head.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria.

The document is a 510(k) summary for the UNI-ROM™ Femoral Hip Stem, submitted in 1998. It primarily focuses on demonstrating substantial equivalence to previously marketed devices (S-ROM Femoral Hip Stem and P.F.C. 2 Femoral Stem).

Here's why the requested information cannot be extracted from the provided text:

Acceptance Criteria/Reported Device Performance: The document describes the physical characteristics, materials, and intended use of the UNI-ROM™ Femoral Hip Stem and compares it to predicate devices in a "Similarities and Differences Matrix." It states that "The determination of substantial equivalence for this device was based in part on bench top performance data," but it does not provide any specific acceptance criteria, benchmarks, or quantitative performance data from these bench tests.
Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): As no performance study results are detailed, there is no information on sample sizes, data origins, expert involvement, adjudication methods, or separate standalone or MRMC studies. Ground truth establishment for any such studies is also not mentioned. The "bench top performance data" mentioned is not elaborated upon in a way that would allow for these details to be extracted.

In summary, the document establishes the substantial equivalence of the UNI-ROM™ Femoral Hip Stem largely based on design, materials, and intended use similarities to predicate devices, and alludes to some bench testing, but it does not provide the detailed performance study information requested.

Summary

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Exhibit I

510(k) Summary UNI-ROM™ Femoral Hip Stem

FEB - 6 1998 1974351

Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

1. Contact Person:

Janet G. Johnson Associate Regulatory Affairs Specialist (508) 828-3466

Device Information: 2.

Proprietary Name:	UNI-ROM™ Total Hip System FemoralStem
Common Name:	Femoral Stem Prostheses
Classification Name:	Hip joint metal/polymer/metal semi-constrained porous-coated uncementedprosthesis
Regulatory Class:	Class II, per 21 §CFR 888.3358
Product Code:	87 LPH

3. Substantial Equivalence:

The UNI-ROM™ Femoral Hip Stem is substantially equivalent in terms of intended use, materials, design, manufacturing processes, sterilization method, packaging and performance to the S-ROM Femoral Hip Stem (K961939, K954935 and K851422) and P.F.C. 2 Femoral Stem (K945518 and K935452).

4. Indications for Use:

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5. Physical Description:

The UNI-ROM™ Femoral hip stem can be used in either the right or left hip and mates with the femoral hip head using an 11/13 Morse-type taper. Further, the femoral stem is designed to accept an S-ROM Co-Cr Femoral head or an S-ROM Ceramic Femoral Head.

The determination of substantial equivalence for this device was based in part on bench top performance data.

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Similarities and Differences Matrix

	UNI-ROM™Femoral HipStem	S-ROM®Femoral HipStem (K961939,K954935 andK851422)	P.F.C. 2 FemoralStem - SizeSmall (K945518and K935452)
DESIGN
Femoral Headlocks onto the stemwith a Morse-typetaper lock	Yes	Yes	Yes
Intended for non-cemented fixation	Yes	Yes	Yes
Distal Slot	Yes	Yes	No
Distal Flutes	Yes	Yes	Yes
Adjunct to a TotalHip System	Yes	Yes	Yes
AnatomicallyShaped	Yes	Yes	Yes
Press Fit	Yes	Yes	Yes
Porous Coating	Proximal	Proximal Sleeve	Proximal
Recommended foruse with:	Femoral Headswith a 11/13Morse TypeTaper	Femoral Headswith a 11/13Morse TypeTaper	Femoral Headswith a 10/12Morse TypeTaper
INTENDED
Indicated for use inprimary hipreplacementprocedures.	Yes	Yes	Yes
MATERIALS
Ti-6Al-4V Substrate	Yes	Yes	Yes
Commercially PureTitanium PorousCoating	Yes	Yes	No
Ti-6Al-4V PorousCoating	No	No	Yes

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Image /page/3/Picture/1 description: The image is a black and white 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 a stylized image of an eagle with three overlapping wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 6 1998

Ms. Janet G. Johnson · Associate Regulatory Affairs Specialist Johnson and Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K974331 UNI-ROM™ Femoral Hip Stem Trade Name: Regulatory Class: II Product Code: LPH Dated: November 17, 1997 Received: November 18, 1997

Dear Ms. Johnson:

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 The general controls provisions of the Act 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. A 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. Janet G. Johnson

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,

Celia M. Witten, Ph.D.

Celta 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) Device Name

UNI-ROM™ Femoral Hip Stem

~ Indications For Use:

The UNI-ROM™ Total Hip System Femoral Stem is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General Restorative Devices K974331 510(k) Number .

Prescription Use X (Per 21 CFR §801.109)

Over-the-Counter Use

(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.