The Global Modular Replacement System (GMRS™) Pediatric Tibial Bearing Component is intended to be used to mate the distal femoral components of the Global Modular Replacement (GMRS™) System or the femoral components of the Modular Rotating Hinge (MRH) System to the Pediatric All Polyethylene Tibial Components of the Modular Replacement System The indications for use for the GMRS™ Pediatric Tibial Bearing Component are listed below:

Replacement of the distal femur and/or proximal tibia in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This smaller size component is intended to be used in patients with a smaller bone structure, or in skeletally immature patients. This component is intended for use with bone cement.

Device Description

The GMRS™ Pediatric Tibial Bearing Component is a single use device that is available in one size. The GMRS™ Pediatric Tibial Bearing Component is designed to mate with the all sizes of the femoral components of the GMRS™ or the MRH systems, and the MRS pediatric all poly tibial components. The design of this GMRS™ Pediatric Tibial Component is similar to the design of the existing MRH XS/XL Tibial Bearing Component - this component is stemmed, and connects to the femoral component by a set of bushings and an axle. A bumper locks this assembly. In terms of dimensions, the subject The GMRS™ Pediatric Bearing has a smaller distal stem diameter, and reduced anterior-posterior and medio-lateral dimensions when compared to the MRH XS/XL Tibial Bearing Component. These reduced dimensions are identical to those seen in the MRS Pediatric Tibial Bearing Component.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, the Global Modular Replacement System (GMRS™) Pediatric Tibial Bearing Component. It focuses on demonstrating substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the way a diagnostic AI product might.

Therefore, many of the requested categories (like sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of submission.

However, I can extract information related to the device description and the method used to demonstrate equivalence.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a diagnostic performance study (e.g., sensitivity, specificity thresholds). Instead, the pivotal point for device acceptance in a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Functional Equivalence: Device performs the same intended use.	Intended Use: "mate the distal femoral components of the Global Modular Replacement (GMRS™) System or the femoral components of the Modular Rotating Hinge (MRH) System to the Pediatric All Polyethylene Tibial Components of the Modular Replacement System." (Page 1) This is identical to predicate devices.
Technological Equivalence: Device has similar technological characteristics.	Design Similarity: "The design of this GMRS™ Pediatric Tibial Component is similar to the design of the existing MRH XS/XL Tibial Bearing Component - this component is stemmed, and connects to the femoral component by a set of bushings and an axle. A bumper locks this assembly." (Page 2)
Material Equivalence: Device uses similar materials.	(Not explicitly detailed in the provided text, but implied by "similar technological characteristics" of other metal/polymer constrained cemented prostheses)
Performance Equivalence: Device performs as safely and effectively as the predicate.	Performance Evaluation Method: "Finite element analysis (FEA) was presented to support a claim of substantial equivalence." (Page 3) No specific FEA results or thresholds are given in this summary.
Biocompatibility: (Implied, not explicitly detailed for this component in the summary)	(Not detailed in the provided text)
Sterility: (Implied, as it's a single-use device)	(Not detailed in the provided text)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. This was not a clinical trial with a "test set" in the context of diagnostic performance. The evaluation was based on a comparison to predicate devices and engineering analysis.
Data Provenance: Not applicable in the context of clinical data. The "data" provided was primarily design specifications and an engineering analysis (FEA) comparing the new device to existing designs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. There was no "test set" requiring ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There was no "test set" requiring adjudication.

5. 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 mechanical orthopedic implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a mechanical orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the conventional sense. The "ground truth" for this submission revolves around the design, materials, and functional equivalence to already approved predicate devices. The primary evidence presented was Finite Element Analysis (FEA), which is a computational method to predict how a product reacts to forces, heat, fluid flow, and other physical effects. Its "truth" is based on established engineering principles and validation against physical testing methods, though no specific validation data is in this summary.

8. The sample size for the training set

Not applicable. There was no "training set."

9. How the ground truth for the training set was established

Not applicable. There was no "training set."

Summary

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

K031480 - Page 1 of 3

JUL 3 1 2003

510(k) Summary

Submission Information
Name and Address of Sponsor:	Howmedica Osteonics Corp.59 Route 17Allendale, NJ 07401
For Information contact:	Margaret F. CroweRegulatory Affairs ConsultantHowmedica Osteonics Corp.59 Route 17Allendale, NJ 07401
Device Identification
Proprietary Name:	Global Modular Replacement System PediatricTibial Bearing Component
Common Name:	Modular Rotating Hinge Knee System
Classification Name and Reference:	Knee joint femorotibial metal/polymerconstrained cemented prosthesis21 CFR §888.3510
Proposed Regulatory Class:	Class II
Device Product Code:	OR(87) KRO

Intended Use

Indications

Replacement of the distal femur and/or proximal tibia in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where

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

radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This smaller size component is intended to be used in patients with a smaller bone structure, or in skeletally immature patients. This component is

Contraindications

A. As related to Bone Tumors
intended to be implanted using bone cement.

Not all bone tumors may be treated successfully by segmental resection. Any condition that may have already resulted in either local or distant spread of the tumor may be a contraindication. Examples of such conditions include:

pathological fracture; .
. overt infection;
. inopportune placement of biopsy incision; and,
rapid disease progression beyond a respectable margin. .
B. As related to Failed Previous Prosthesis and Trauma
Any active or suspected latent infection in or about the affected joint. .
Any mental or neuromuscular disorder which would create an unacceptable risk of . prosthesis instability, prosthesis fixation failure, or complication in postoperative care.
Bone stock compromised by disease, infection, or prior implantation that cannot . provide adequate support and fixation of the prosthesis.

Device Description

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

of bushings and an axle. A bumper locks this assembly. In terms of dimensions, the subject The GMRS™ Pediatric Bearing has a smaller distal stem diameter, and reduced anterior-posterior and medio-lateral dimensions when compared to the MRH XS/XL Tibial Bearing Component. These reduced dimensions are identical to those seen in the MRS Pediatric Tibial Bearing Component.

Equivalent products include the MRS Pediatric Tibial Bearing Component (Howmedica Osteonics Corp.) and the MRH Crossover Tibial Bearing Component (Howmedica Osteonics Corp.).

Finite element analysis (FEA) was presented to support a claim of substantial equivalence.

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

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2003

Mr. William J. Cymbaluk Vice President, Quality Assurance/Regulatory Affairs/Clinical Research Howmedica Osteonics Corp. 59 Route 17 South Allendale, New Jersey 07401

K031480 Re:

Device Name: Global Modular Replacement System (GMRS™) Pediatric Tibial Bearing Component Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: May 9, 2003 Received: May 12, 2003

Dear Mr. Cymbaluk:

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

{4}------------------------------------------------

Page 2 - Mr. William J. Cymbaluk

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. 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), 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). You may obtain other general information on your responsibilities under the Act 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 N. Milliken

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

{5}------------------------------------------------

GMRS™ Pediatric Tibial Bearing Component Confidential

510(k) Premarket Notification

510(k) Number (if known): K 03 (480

GMRS™ Pediatric Tibial Bearing Component Device:

The Global Modular Replacement System (GMRS™) Pediatric Tibial Bearing Component is intended to be used to mate the distal femoral components of the Global Modular Replacement (GMRS™) System or the femoral components of the Modular Rotating Hinge (MRH) System to the Pediatric All Polyethylene Tibial Components of the Modular Replacement System The indications for use for the GMRS"" Pediatric Tibial Bearing Component are listed below:

Indications

Contraindications

As related to Bone Tumors A.
Not all bone tumors may be treated successfully by segmental resection. Any condition that may have already resulted in either local or distant spread of the tumor may be a contraindication. Examples of such conditions include:
pathological fracture; .
overt infection; .
inopportune placement of biopsy incision; and, .
rapid disease progression beyond a respectable margin. .
B. As related to Failed Previous Prosthesis and Trauma

for Mark H. Millener

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

510(k) Number K 031480

{6}------------------------------------------------

Any active or suspected latent infection in or about the affected joint. .
Any mental or neuromuscular disorder which would create an unacceptable risk of . prosthesis instability, prosthesis fixation failure, or complication in postoperative care.
Bone stock compromised by disease, infection, or prior implantation that cannot . provide adequate support and fixation of the prosthesis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR 801.109)

Over-the Counter-Use

Mark A. Melkers

(Division Sign-Off) eneral. Restorative Division o and Neurological Devices 031486

510(k) Number -

Regulation Number and Section

§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.