The Protrusio implants are intended for use in reconstruction of the hip joint due to disease, deformity or trauma. The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery. The device is a single use implant. The Protrusio Cage is to be used in conjunction with any commercially available polyethylene acetabular cup.

Device Description

This series of six anatomic protrusio cages is manufactured from Titanium. Each cage has two illac flanges positioned superiorly and one ischial flange positioned inferiorly that provide supplemental screw fixation holes for attachment to the ilium. These cages, once positioned in the acetabulum and attached to the ilium and ischium, provide structural integrity to an otherwise structurally compromised joint. The device is a single use implant intended for implantation with bone cement. In cases where bony defects or voids exist, optional augments can be utilized to help provide additional structural support. The augments are attached to the cage by means of a locking screw.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Patriot Protrusio Cage). It explicitly states:

"Clinical Testing: None provided as a basis for substantial equivalence."

This means that no clinical study was conducted or submitted to demonstrate the device meets any specific acceptance criteria. The submission relies on "substantial equivalence" to predicate devices, which means the manufacturer asserts the new device is as safe and effective as a legally marketed device that does not require premarket approval.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be provided from this document.

For completeness, I will explain why each point cannot be addressed:

A table of acceptance criteria and the reported device performance: No acceptance criteria are stated, and no performance data from a clinical study is reported.
Sample size used for the test set and the data provenance: No clinical test set was used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set was used.
Adjudication method for the test set: Not applicable as no clinical test set was used.
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 physical implant, not an AI-based diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical data was submitted.
The sample size for the training set: Not applicable as no algorithm was developed or clinical training set used.
How the ground truth for the training set was established: Not applicable as no algorithm was developed or clinical training set used.

Summary

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JAN 3 0 2002

K020076
page 1 of 1

ARTERS CORPORATE

SUMMARY OF SAFETY AND EFFECTIVENESS

Sponsor:

Biomet. Inc. 56 East Bell Drive P.O. Box 587 Warsaw, In. 46581-0587

Contact Person:

Tracy Bickel (219) 267-6639

Proprietary Name:

Common Name:

Acetabular Component

Patroit Protrusio Cage

Classification Name:

Hip joint metal/polymer/metal semi-constrained uncemented prosthesis (888.3358)

Patriot Protrusio Cage - K001376 Substantially Equivalent Devices:

This series of six anatomic protrusio cages is manufactured from Titanium. Each cage Device Description: has two illac flanges positioned superiorly and one ischial flange positioned inferiorly that provide supplemental screw fixation holes for attachment to the ilium. These cages, once positioned in the acetabulum and attached to the ilium and ischium, provide structural integrity to an otherwise structurally compromised joint.

The device is a single use implant intended for implantation with bone cement.

In cases where bony defects or voids exist, optional augments can be utilized to help provide additional structural support. The augments are attached to the cage by means of a locking screw.

Intended use: The Protrusio implants are intended for use in reconstruction of the hip joint due to disease, deformity or trauma. The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery. The device is a single use implant. The Protrusio Cage is to be used in conjunction with any commercially available polyethylene acetabular cup.

The Patriot Protrusio Cage material, design, sizing, and indications are similar Summary of Technologies: to or identical to the predicate devices.

Non-Clinical Testing: Testing determined that Patriot Protrusio Cage components presented no new risks and were: therefore, substantially equivalent to the predicate device.

Clinical Testing: None provided as a basis for substantial equivalence.

All Trademarks are property of Biomet, Inc.

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

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639

FAX 219.267.8137

E-MAIL רחוגet@biomet.corret.corret.co

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2002

Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

K020076 Re:

Trade Name: Patriot Protrusio Cage Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/ metal semiporous-coated uncemented prosthesis Regulatory Class: II Product Code: JDI Dated: January 7, 2002 Received: January 9, 2002

Dear Ms. Bickel:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootion of re(i) prother is substantially equivalent (for the relerenced above and we have decembliod the evices marketed in interstate commerce prior to indications for use stact in the energian of the Medical Device Amendments, or to devices that have May 26, 1970, the chaculten date of the Frederal Food, Drug, and Cosmetic Act
been reclassified in accordance with the provisions of the Federal Food, Drug, March Way been recrassified in accordance will a premarket approval application (PMA). You may, (Act) that do not require approval of to the general controls provisions of the Act. The general therefore, market the device, subject to the generals for annual registration, listing of devices. controls provisions of the rice merace sont prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 a0070) als. Existing major regulations affecting your device can may be subject to such additional controller "Little 21, Parts 800 to 898. In addition, FDA may oc found in the Souv acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease oc advised that I DTT 3 ibsunted or our device complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must of any I catales and regarations and regarations and limited to: registration and listing (21 Comply with an the Aot 8 requirements, only, good manufacturing practice requirements as set CI K Fat 807), adomig (21 OFR Part 820); and if applicable, the electronic forth in the quality 35sems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Tracy J. Bickel

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in yourse ough finding of substantial equivalence of your device to a legally promaticated predicated for 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 11 you desire specific ad 100 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 0071. Additionally, for questions on the promotion and advertising of Compliance at (301) 591-1697 Fridae 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 Oinor 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 N. Milken

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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Page _ of _

510(k) Number (if known): __ ko2 0276 Device Name: Patriot Protrusio Cages Indications for Use:

The Protrusio implants are intended for use in reconstruction of the hip joint due to disease, The Frounds in plants are intended for general use in skeletally mature individuals.
deformity or trauma. The devices are intended for general use in a mass implant undergoing primary and/or secondary revision surgery. The device is a single lise implant. undergoting primary and/or socondary revision with any commercially available polyethylene acetabular cup.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✗
OR
(Per 21 CFR 801,109)
for
Mark A. Melhern
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K020076

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

0007b

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.