COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM by BIOMET, INC.

Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
Tumor resections
Revision of previously failed total joint arthroplasty
Trauma
The ComPreSs® Distal Femoral Replacement components are intended for uncemented use only.

Device Description

The ComPreSs® Distal Femoral Replacement System consists of three main components, the anchor plug, the spindle assembly, and the intercalary segment. The Anchor Plug is embedded within the medullary canal, the Spindle Assembly attaches to the Anchor Plug and is compressed against the bone / implant interface at the osteotomy site. The Intercalary Segment attaches to the Spindle Assembly, and completes the Femoral Stem Component.

AI/ML Overview

The provided text describes a 510(k) submission for the ComPreSs® Distal Femoral Replacement System. This document focuses on establishing substantial equivalence to predicate devices for a medical implant, rather than reporting on a study demonstrating device performance against specific acceptance criteria in the way a diagnostic or AI device study would.

Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, etc.) are not applicable or not present in this type of submission.

Here's why and what information can be extracted:

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

The submission does not present acceptance criteria and performance data in the typical sense for a diagnostic device. Instead, it demonstrates substantial equivalence for the ComPreSs® Distal Femoral Replacement System to legally marketed predicate devices. The "performance" here is defined by meeting the same safety and effectiveness profiles as the predicates.

Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical Equivalence of Tapers: Tapers incorporated into these components are substantially equivalent to those in predicate devices.	Mechanical testing was done on the tapers. This testing, along with engineering justification, indicated that the tapers incorporated into these components are substantially equivalent to the tapers used in the predicate devices.
Hydroxyapatite Coating Effect on Device Strength: Addition of Hydroxyapatite coating does not weaken the devices.	The Hydroxyapatite coating on the Hydroxyapatite coated spindles was previously tested with porous coating, and the testing concluded that the addition of Hydroxyapatite coating did not weaken the devices tested.
Material Equivalence (Hydroxyapatite coated spindles): Identical in material, function, design, and sizing as predicate spindles.	The Hydroxyapatite coated spindles are identical in material, function, design, and sizing as the predicate spindles. The only change is the addition of Hydroxyapatite coating.
Material Equivalence (Taper Adapters): Made of the same material, with the same taper geometries as predicate tapers.	The ComPreSs / OSS / Finn® Taper Adapters are made of the same material, with the same taper geometries as the predicate OSS tapers, the ComPreSs® Distal Femoral Replacement tapers, or the Finn® tapers included in the predicate ComPreSs® Distal Femoral Replacement.

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

Sample Size: Not applicable. The "test set" here refers to mechanical testing of components, not a clinical data set. The document does not specify the number of components tested for mechanical equivalence.
Data Provenance: Not applicable. This refers to engineering and laboratory testing rather than clinical data from patients.

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. "Ground truth" in this context would typically refer to clinical diagnosis or outcome, which is not part of this 510(k) submission. The evaluation is based on mechanical testing and engineering justification by presumably qualified engineers.

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

Not applicable. Adjudication is irrelevant for mechanical testing of device components.

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 device is a surgical implant, not a diagnostic or AI-assisted device. MRMC studies are not relevant to its evaluation.

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

Not applicable. This device is a surgical implant, not an algorithm.

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

The "ground truth" used for demonstrating substantial equivalence is based on accepted engineering principles, mechanical testing standards, and comparison to the design and materials of predicate devices. There is no clinical "ground truth" generated as part of this submission, as clinical testing was not required.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; therefore, there is no "training set."

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

Not applicable. There is no training set for this device.

Summary

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.1111 3 0 2004

BIOMET

510(k) Summary

Applicant or Sponsor:	Biomet Manufacturing Corp.56 East Bell DriveP.O. Box 587Warsaw, Indiana 46581-0587
Contact Person:	Gary BakerBiomet Manufacturing Corp.P.O. Box 587Warsaw, Indiana 46581-0587Phone: (574) 267-6639FAX: (574) 372-1683
Proprietary Name:	ComPreSs® Distal Femoral Replacement
Common Name:	Segmental Femoral Stem Component
Classification Name:	Prosthesis, Knee, Femorotibial, Constrained, CementedMetal/Polymer (21 CFR §888.3510).

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

1. ComPreSs® Distal Femoral Replacement Biomet Inc. (K031804).
1. Modular Replacement System Howmedica Inc. (K972401).
Finn® Knee System Biomet Inc. (K945028). 3.
Oncology Salvage System Biomet Inc. (K002757). 4.

Device Description:

109

MAHING ADDRESS 170. 130x 587 Warsaw, IN 46581-0587

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

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ドハメ 5712078137

E-MAIL わiのmでない】 ion re4.com

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The ComPreSs® Distal Femoral Replacement System is intended for Intended Use: uncemented use.

Indications for Use: The ComPreSs® Distal Femoral Replacement System is intended for:

Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement

1. Tumor resections
1. Revision of previously failed total joint arthroplasty
1. Trauma

Summary of Technologies: The Hydroxyapatite coated spindles are identical in material, function, design, and sizing as the predicate spindles. The only change is the addition of Hydroxyapatite coating. The ComPreSs / OSS / Finn® Taper Adapters are made of the same material, with the same taper geometries as the predicate OSS tapers, the ComPreSs® Distal Femoral Replacement tapers, or the Finn® tapers included in the predicate ComPreSs® Distal Femoral Replacement.

Non-Clinical Testing: Mechanical testing was done on the tapers. This testing, along with engineering justification, indicated that the tapers incorporated into these components are substantially equivalent to the tapers used in the predicate devices. The Hydroxyapatite coating on the Hydroxyapatite coated spindles was previously tested with porous coating, and the testing concluded that the addition of Hydroxyapatite coating did not weaken the devices tested.

Clinical Testing: Clinical testing was not required for these components to support substantial equivalence.

All trademarks are property of Biomet, Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2004

Mr. Gary Baker Regulatory Specialist Biomet Manufacturing Corporation 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581

Re: K041352

Trade/Device Name: ComPreSs® Distal Femoral Replacement System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: May 19, 2004 Received: May 20, 2004

Dear Mr. Baker:

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 r ou mayy ato s provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitiors 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.

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Page 2 - Mr. Gary Baker

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w Jourse of substantial equivalence of your device to a legally premaince notification. The 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 if you active of Compliance at (301) 594-4659. Also, please note the regulation entitled, Contider the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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. McKenna

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

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Indications For Use

KO41352 510(k) Number (IF KNOWN):

Device Name: ComPreSs® Distal Femoral Replacement System.

Indications for Use:

1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
1. Tumor resections
1. Revision of previously failed total joint arthroplasty
1. Trauma

The ComPreSs® Distal Femoral Replacement components are intended for uncemented use only.

L AND/OR Prescription Use (Per 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mellinss

Division of General, Restorative, and Neurological Devices

510(k) Num'er K041352

Page 1 of 1

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.