The indications for the Rx 90™ Femoral Stems and Rx 90™ Lateralized Femoral Stems are for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Correction of functional deformity; 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) Revision procedures where other treatments or devices have failed. This device is to be used with bone cement.

Device Description

The Rx 90™ Femoral Components have been modified to include, not only a lateralized version to expand its product line, but also additional sizes including a smaller stem, a reduced collar and a "smooth" finish.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a medical device, the Rx 90™ Femoral Stems and Rx 90™ Lateralized Femoral Stems. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than proving device performance against specific clinical acceptance criteria in the way new diagnostic or therapeutic AI devices do.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/diagnostic device is not applicable to this submission.

Here's why and what information is relevant to this document:

Type of Device and Submission: The Rx 90™ Femoral Stem is a metallic total hip femoral component, a physical implant. The submission is a 510(k), which aims to show the new device is "substantially equivalent" to a legally marketed predicate device (K924028, Rx 90™ Femoral Components).
Focus of 510(k): For physical medical devices of this nature, substantial equivalence is typically demonstrated through comparisons of materials, design, sizing, indications for use, and mechanical non-clinical testing. Clinical testing is often not required if these similarities are sufficient, as explicitly stated in the document.

Information from the document related to substantial equivalence, which is the "acceptance criteria" for a 510(k) submission:

Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance/Evidence from Submission
Similarity/Identity to Predicate Device (K924028, Rx 90™ Femoral Components) in:
- Materials	"The Rx 90™ Femoral Components...the materials, design, sizing, and indications are similar or identical to the predicate devices."
- Design	"The Rx 90™ Femoral Components...the materials, design, sizing, and indications are similar or identical to the predicate devices." (Modifications mentioned: lateralized version, additional sizes, smaller stem, reduced collar, smooth finish. These modifications are asserted not to affect mechanical properties.)
- Sizing	"The Rx 90™ Femoral Components...the materials, design, sizing, and indications are similar or identical to the predicate devices." (Additional sizes, including a smaller stem, are noted as modifications.)
- Indications for Use	"The indications for the Rx 90™ Femoral Stems and Rx 90™ Lateralized Femoral Stems are for 1) Non-inflammatory degenerative joint disease... 2) Rheumatoid arthritis... 3) Correction of functional deformity... 4) Treatment of non-union... and 5) Revision procedures..." (These are stated to be "similar or identical" to predicate devices.)
Mechanical Properties: Modifications should not adversely affect mechanical properties.	"Non-Clinical Testing: Mechanical testing was provided to demonstrate that the modifications do not effect the mechanical properties of the device." (Specific results of this testing are not detailed in the provided summary but are implied to meet equivalence standards.)
Clinical Safety and Effectiveness: No new clinical concerns raised by modifications or new device features.	"Clinical Testing: No clinical testing was provided as a basis for substantial equivalence." (This indicates that the non-clinical data and similarity to the predicate were sufficient to address safety and effectiveness for substantial equivalence without needing clinical trials.)

Sample size used for the test set and the data provenance: Not applicable. No clinical test set data was reported. Mechanical testing was performed, but details on sample size for those tests are not provided in this summary.
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.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.
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 is a physical implant, not an AI or diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. For a physical implant 510(k), "ground truth" is typically established through engineering principles, material science, biomechanical testing standards, and comparison to existing, safe, and effective predicate devices.
The sample size for the training set: Not applicable. There is no "training set" in the context of this device and submission type.
How the ground truth for the training set was established: Not applicable. There is no "training set" in the context of this device and submission type.

Summary

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

K 023085 page 14

OCT 1 7 2002

SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant or Sponsor: Biomet Orthopedics, Inc.

Dalene T. Binkley Contact Person:

Proprietary Name: Rx 90TM Femoral Stems and Rx 90™ Lateralized Femoral Stems

Common Name: Metallic total hip femoral component

Classification: Hip joint metal/polymer/metal semi-constrained cemented prosthesis

Device Classification: Class II

Legally Marketed Device to which Substantially Equivalence is Claimed: Rx 90™ Femoral Components- 510(k) K924028

Device Description: The Rx 90™ Femoral Components have been modified to include, not only a lateralized version to expand its product line, but also additional sizes including a smaller stem, a reduced collar and a "smooth" finish.

Indications for Use: The indications for the Rx 90™ Femoral Stems and Rx 90™ Lateralized Femoral Stems are for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis: 2) Rheumatoid arthritis: 3) Correction of functional deformity; 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and 5) Revision procedures where other treatments or devices have failed.

Summary of Technologies: The Rx 90™ Femoral Stems and Rx 90™ Lateralized Femoral Stems' components-the materials, design, sizing, and indications are similar or identical to the predicate devices.

Non-Clinical Testing: Mechanical testing was provided to demonstrate that the modifications do not effect the mechanical properties of the device.

Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.

MAILING ADDRESS P.O. Box 587 Warsaw. IN 46581-0587

SHIPPING ADDRESS 56 E. Bell Drive Warsaw. IN 46582

00000000

FAX 574.267.8137

E-MAIL biomet@biomet.com

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2002

Ms. Dalene T. Binkley Regulatory Affairs Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K023085

Trade/Device Name: Rx-90™ Femoral Stem and Rx-90™ Lateralized Femoral Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Cemented Prosthesis Regulatory Class: II Product Code: JDI Dated: September 16, 2002 Received: September 17, 2002

Dear Ms. Binkley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean ' that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Ms. Dalene T. Binkley

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Page _ of _

510 (k) NUMBER (IF KNOWN): K023085

DEVICE NAME: Rx 90™ Femoral Stem and Rx 90™ Lateralized Femoral Stem

INDICATIONS FOR USE:

This device is to be used with bone cement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use UK (Per 21 CFR 801.109)

Over-The-Counter-Use No
(Optional Format 1-2-96)

for Mark A. Milleson
Division Sign Off

Division Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number K02309

000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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.