RECOVERY PROTRUSIO CAGE

K971890 · Biomet, Inc. · JDI · Aug 7, 1997 · Orthopedic

Device Facts

• Record ID: K971890
• Device Name: RECOVERY PROTRUSIO CAGE
• Applicant: Biomet, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Aug 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Recovery Protrusio Cage is a hemispherical, malleable, commercially pure (CP) titanium implant designed for acetabular reinforcement in hip joint reconstruction. Used in OR by orthopedic surgeons; device provides structural support for severely deficient acetabula and facilitates bone grafting. Features include grit-blasted surface for cement adherence, dome with screw holes for fixation, two windows for bone impaction/cement mantle, and an inferior obturator foramen hook for stability. Surgeon shapes the titanium flange and hook intraoperatively to match patient anatomy. Device is fixed to the pelvis using 6.5mm low-profile screws and bone cement, which secures an all-polyethylene acetabular cup within the cage. By bridging host bone, the cage resists acetabular migration and protects bone grafts from stress overload, potentially reducing risk of collapse and improving long-term joint stability.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hemispherical cage constructed of malleable commercially pure (CP) titanium. Features grit-blasted surface finish for bone cement adherence. Includes dome with screw holes, two windows for bone impaction, and an inferior obturator foramen hook. Designed for use with 6.5mm low-profile screws and bone cement. Single-use implant.

Indications for Use

Indicated for skeletally mature individuals requiring hip joint reconstruction due to disease, deformity, or trauma, specifically for primary or secondary revision surgery. Must be used with bone cement and a commercially available all polyethylene acetabular cup.

Regulatory Classification

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).

Predicate Devices

• Protek® Acetabular Roof Reinforcement Ring (K953578)
• Bursch/Schneider Reinforcement Cage (K960678)
• Protrusion Cages (K962007)
• Restoration™ GAP Acetabular Cup (K943549)

Submission Summary (Full Text)

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## 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

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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 |

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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.

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- 3. 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.

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## 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 [phone]. Additionally, for questions on... the promotion and advertising of your device, please contact w the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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)