RECOVERY PROTRUSIO CAGE by BIOMET, INC.

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

Device Description

The Recovery Protrusio Cage is a hemispherical metallic cage. This malleable commercially pure (CP) titanium cage can be shaped by the surgeon intraoperatively to fit the proper shape of the patient's anatomy. The surface of the device has a grit blasted (roughened) finish for adherence of bone cement. The purpose of the cage is to provide reinforcement for the acetabular socket and facilitate bone grafting in cases of a severely deficient acetabulum. The pelvic bone grafts are protected from stress overload and potential collapse with the cage. This device can potential resist acetabular migration by serving as a connection between host bone to host bone. The dome of the cage contains five or six screw holes for component fixation. Two large "windows" in the dome allow for morselized bone impaction and a continuous cement mantle lateral and medial of the device. An anterior cut-out in the dome allows retroverted positioning of the cage without causing impingement of the neck and possible dislocation. A large illum flange contains six screw holes for component fixation. This flange is designed for a severely deficient acetabulum to allow engagement of the cage to host bone. An inferior obturator foramen hook is positioned beneath the "teardrop" of the ischium to provide further stability of the cage. The illum flange and the obturator foramen hook can be shaped by the surgeon to properly fit the patient's anatomy. The use of 6.5mm low profile screws placed through any (at least two) or all holes in the dome and large illum flange provide immediate stable fixation of the shell to the pelvis. Adjunctive fixation is achieved with bone cement that adheres an all polyethylene acetabular cup into the shell. The all polyethylene acetabular cup is anteverted to the correct anatomic position within the Recovery cage.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (Recovery® Protrusio Cage), not a study report. It demonstrates substantial equivalence to previously marketed devices rather than presenting a study with acceptance criteria and device performance. Therefore, most of the requested information regarding study details (sample size, experts, ground truth, MRMC study, standalone performance, training set) is not available in this document.

However, I can extract the acceptance criteria for market clearance, which is demonstrating substantial equivalence, and list the comparable predicate devices.

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (for 510(k) Clearance)	Reported Device Performance (as demonstrated for clearance)
Substantial Equivalence to Predicate Devices: The device must be demonstrated to be as safe and effective as a legally marketed predicate device that was in interstate commerce prior to May 28, 1976, or to a reclassified device. This includes demonstrating overall design and intended function are comparable.	The Recovery Protrusio Cage is stated to be substantially equivalent to other acetabular cage devices on the market in overall design and intended function. Specifically, it was deemed equivalent to similar devices labeled and intended to be fixed within bone with acrylic "bone cement."Predicate Devices identified:- Protek® Acetabular Roof Reinforcement Ring (Intermedics Orthopedics, Inc.) - K953578- Bursch/Schneider Reinforcement Cage (Intermedics Orthopedics, Inc.) - K960678- Protrusion Cages (Depuy) - K962007- Restoration™ GAP Acetabular Cup (Osteonics) - K943549
Intended Use: The device's intended use must be clear and comparable to predicate devices.	The Recovery Protrusio Cage is intended for use in reconstruction of the hip joint due to disease, deformity of trauma. It is for cemented application in skeletally mature individuals undergoing primary or secondary revision surgery and to be used with any commercially available all polyethylene acetabular cup. The FDA's clearance explicitly states limitations: "This device may not be labeled or promoted for non-cemented use. All labeling for this device... must prominently state that the device is intended for cemented use only."
Materials and Design: Should be comparable to safe and effective predicate devices, or adequately justified.	The device is described as a hemispherical metallic cage made of malleable commercially pure (CP) titanium with a grit blasted (roughened) finish for cement adherence. This design and material selection are presented as comparable to existing acetabular cages.
Risks: Potential risks associated with the device should be identified and comparable to predicate devices.	The document lists potential risks "the same as with any joint replacement device," including cement reaction, fracture of components/bone/cement, hematoma, cardiovascular/nerve/blood vessel damage, implant loosening/migration, soft tissue imbalance, excessive wear, deformity, infection, dislocation, delayed wound healing, and metal sensitivity.

Important Note: This document represents the regulatory clearance process (510(k)) based on substantial equivalence, not a clinical trial or performance study report. Therefore, it does not contain the detailed study information typically found in such reports.

The following points cannot be answered from the provided text:

Sample size used for the test set and the data provenance: Not applicable, as this is a regulatory submission based on substantial equivalence, not a clinical study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 or imaging diagnostic tool that would involve human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Substantial equivalence relies on comparison to known predicate devices, not on a new ground truth established for this specific device.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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

SUMMARY OF SAFETY AND EFFECTIVENESS AUG - 7 1997

Sponsor:

Biomet, Inc. Airport Industrial Park Warsaw. Indiana 46580

Recovery® Protrusio Cage Device:

Classification: Hip ioint metal/polymer semi-constrained cemented prosthesis (88.3350).

Intended Use: The Recovery Protrusio Cage is intended for use in reconstruction of the hip joint due to disease, deformity of trauma.

The device is intended for cemented application for general use in skeletally mature individuals undergoing primary or secondary revision surgery.

The device is a single use implant.

The device is to be used in conjunction with any commercially available all polyethylene acetabular cup.

Device Description: The Recovery Protrusio Cage is a hemispherical metallic cage. This malleable commercially pure (CP) titanium cage can be shaped by the surgeon intraoperatively to fit the proper shape of the patient's anatomy. The surface of the device has a grit blasted (roughened) finish for adherence of bone cement.

The purpose of the cage is to provide reinforcement for the acetabular socket and facilitate bone grafting in cases of a severely deficient acetabulum.14 The pelvic bone grafts are protected from stress overload and potential collapse with the cage. This device can potential resist acetabular migration by serving as a connection between host bone to host bone.1

The dome of the cage contains five or six screw holes for component fixation. Two large "windows" in the dome allow for morselized bone impaction and a continuous cement mantle lateral and medial of the device. An anterior cut-out in the dome allows retroverted positioning of the cage without causing impingement of the neck and possible dislocation.

A large illum flange contains six screw holes for component fixation. This flange is designed for a severely deficient acetabulum to allow engagement of the cage to host bone. An inferior obturator foramen hook is positioned beneath the "teardrop" of the ischium to provide further stability of the cage. The illum flange and the obturator foramen hook can be shaped by the surgeon to properly fit the patient's anatomy.

The use of 6.5mm low profile screws placed through any (at least two) or all holes in the dome and large illum flange provide immediate stable fixation of the shell to the pelvis. Adjunctive fixation is achieved with bone cement that adheres an all polyethylene

000079

118 9 9 ( )

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

acetabular cup into the shell. The all polyethylene acetabular cup is anteverted to the correct anatomic position within the Recovery cage.

Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:

Reaction to bone cement	Bone fracture
Fracture of the components	Hematoma
Cardiovascular disorders	Blood vessel damage
Implant loosening/migration	Nerve damage
Soft tissue imbalance	Excessive wear
Deformity of the joint	Infection
Dislocation	Delayed wound healing
Metal sensitivity	Fracture of the cement

Substantial Equivalence: The Recovery Protrusio Cage is substantially equivalent to other acetabular cage devices on the market in overall design and intended function. Previously 510(k) cleared competitive acetabular components include:

Protek® Acetabular Roof Reinforcement Ring (Intermedics Orthopedics, Inc., Austin, TX) - 510(k) K953578
Bursch/Schneider Reinforcement Cage (Intermedics Orthopedics, Inc., Austin, TX) - 510(k) K960678
Protrusion Cages (Depuy, Warsaw, IN) - 510(k) K962007
Restoration™ GAP Acetabular Cup (Osteonics, Allendale, NJ) - 510(k) K943549

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

Image /page/2/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 perimeter. In the center of the seal is an abstract design of three human profiles, which are meant to represent the department's mission of promoting health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Deborah M. Matarazzo, R.N., B.S.N. Clinical Research Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

AUG - 7 15.91

Re : K971890 Recovery Protrusio Cage Requlatory Class: II Product Code: JDI Dated: May 19, 1997 Received: May 22, 1997

Dear Ms. Matarazzo:

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, Druq, and Cosmetic Act (Act). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:

1. This device may not be labeled or promoted for non-cemented use.
All labeling for this device, including package label and 2. labeling included within the package, must prominently state that the device is intended for cemented use only.

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

1. Any non-cemented fixation of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for ----non-cemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investiqation.
  The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practices, 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 Requlations, 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 requlation may result in requlatory 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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

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

Page 3 - Deborah M. Matarazzo, R.N., B.S.N.

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 w 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,

Ascollifo

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

Enclosure

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

Page I of 1

K 971890 510(k) Number (if known): __ Prototosic. Recovery C a age Device Name:

Indications For Use: The Recovery Protrusio Cage is intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device
is intended for cemented application for general use in skeletally marce single use implant. The device is to be used in conjunction with any commercially ------available polyethylene acetabular cup.

(FITALE DO NOT MRILE BETON THIS LINE - CONTINIE OR ANOTHER BUCE IF ARREDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off)
	Division of General Restorative Devices

510(k) Number	K971890
---------------	---------

Prescription Use	OR	Over-The-Counter Use_
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

N/A