COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM

K112905 · Biomet Orthopedics, LLC · MBF · May 24, 2012 · Orthopedic

Device Facts

• Record ID: K112905
• Device Name: COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM
• Applicant: Biomet Orthopedics, LLC
• Product Code: MBF · Orthopedic
• Decision Date: May 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3670
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Compress® Segmental Humeral Replacement System is intended to replace the resected part of the humerus in cases of severe bone loss in either the proximal or distal humerus. The Compress® Segmental Humeral Replacement System components are intended for uncemented use.

Device Story

The Compress® Segmental Humeral Replacement System is a metallic segmental fixation device designed to replace resected humeral bone segments. It utilizes an integrated spring system within the stem to apply compressive load at the prosthetic-bone interface upon insertion, facilitating uncemented fixation. The system is used by orthopedic surgeons in clinical settings to address severe bone loss resulting from tumor resection, trauma, or failed prior arthroplasty. By providing stable, compressive fixation, the device aims to restore structural integrity to the humerus. It may be used in conjunction with the Discovery Elbow or Modular Hybrid Glenoid components, which typically require bone cement for fixation.

Clinical Evidence

No clinical data was performed. Substantial equivalence was demonstrated through non-clinical bench testing, specifically cyclic fatigue testing of the Mini Compress® taper to ten million cycles and taper pull-off strength testing, both of which met acceptance criteria.

Technological Characteristics

Metallic segmental fixation system featuring a spring-loaded stem for compressive load application. Components are designed for uncemented use. Materials include porous titanium (optional pegs). Testing includes cyclic fatigue and pull-off strength. No software or electronic components.

Indications for Use

Indicated for patients requiring correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement; tumor resections; revision of previously failed total joint arthroplasty; or trauma. Components are for uncemented use. Associated Discovery Elbow and Modular Hybrid Glenoid components are restricted to these indications and intended for cemented use, except for optional porous titanium pegs.

Regulatory Classification

Identification

A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”

Predicate Devices

• Compress® Segmental Femoral Replacement System (Anti-Rotation Spindles) (K101475)
• Compress® Segmental Femoral Replacement System (Short Spindle and Anchor Plug) (K062998)
• Discovery™ Elbow – Mosaic™ Distal Humeral Replacement System (K033280)
• 3-Piece Proximal Humeral Replacement System (Mosaic) (K020045)

Submission Summary (Full Text)

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<112905

MAY 2 4 2012

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# 510(k) Summary

| Preparation Date: | 20 September, 2011 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant/Sponsor: | Biomet Manufacturing Corp.<br>56 East Bell Drive<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587<br>FDA Registration Number: 1825034 |
| Contact Person: | Gary Baker, MS RAC<br>Senior Regulatory Specialist<br>Biomet Orthopedics LLC.<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587<br>Phone: [phone] Ext. 1568<br>Fax: [phone]<br>[e-mail] |
| Proprietary Name: | Compress® Segmental Humeral Replacement System |
| Common Name: | Proximal or Distal Humeral Replacement prostheses |
| Classification Name: | MBF - Shoulder joint metal/polymer/metal non-constrained or<br>semi-constrained porous-coated uncemented prosthesis.<br>KWS - Shoulder joint metal/polymer semi-constrained cemented<br>prosthesis |

KWT - Shoulder joint metal/polymer non-constrained cemented prosthesis

JDC – Elbow joint metal/polymer constrained cemented prosthesis

Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800.348.9500 Office: 574.267.6639
Main Fax: [phone]
Main Fax: [phone]
www.biomet.com Shipping Address: 56 East Bell Drive
Warsaw, IN 46582

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K112905

# Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

| Biomet - K101475 - | Compress® Segmental Femoral Replacement System (Anti-Rotation<br>Spindles) |
|--------------------|-----------------------------------------------------------------------------------|
| Biomet - K062998 - | Compress® Segmental Femoral Replacement System (Short Spindle and<br>Anchor Plug) |
| Biomet - K033280 - | Discovery™ Elbow – Mosaic™ Distal Humeral Replacement System |
| Biomet - K020045 - | 3-Piece Proximal Humeral Replacement System (Mosaic) |

#### Device Description:

The Compress® Segmental Humeral Replacement System is a metallic segmental fixation system intended to replace the resected part of the humerus in cases of severe bone loss. The design of the Compress® System allows a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. This is accomplished through a spring system built into the stem.

#### Intended Use:

The Compress® Segmental Humeral Replacement System is intended to replace the resected part of the humerus in cases of severe bone loss in either the proximal or distal humerus. The Compress® Segmental Humeral Replacement System components are intended for uncemented use.

#### Indications for Use:

The Compress® Segmental Humeral Replacement System is indicated for:

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

The Compress® Segmental Humeral Replacement System components are intended for uncemented use.

The Discovery Elbow components when used in conjunction with the Compress® Segmental Humeral Replacement System are restricted to the Compress® Segmental Humeral Replacement System indications and are intended to be inserted with bone cement.

The Modular Hybrid Glenoid when used in conjunction with the Compress® Segmental Humeral Replacement System is restricted to the Compress® Segmental Humeral Replacement System indications and is intended to be used with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

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# K112905

## Summary of Technologies:

The Compress® Segmental Humeral Replacement System is a set of Compliant - Pre-Stress implants that replace the humeral stems that would normally be used during a proximal or distal humeral replacement surgery.

# Non-Clinical Testing:

# MT-5325 – Mini Compress® Taper Fatigue Test:

Cyclic Fatigue testing of the Mini Compress® taper indicated that all test specimens passed cyclic fatigue testing to ten million cycles without failure.

# MT-5326 – Mini Compress® Pull-off Test:

Taper pull-off testing was conducted to determine the pull-off strength of the Mini Compress® taper. Each individual specimen exceeded the minimum acceptance criterion, as did the average pull-off strength.

#### Clinical Testing:

Clinical testing was not performed to demonstrate substantial equivalence of the subject Compress® Segmental Humeral Replacement System components with the predicate Compress® Segmental Femoral Replacement System components.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or other bird-like figure, depicted with three curved lines forming its body and wings.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 2 4 2012

Biomet Manufacturing Corporation % Mr. Gary Baker, MS RAC Senior Regulatory Specialist 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587

Re: K112905

Trade/Device Name: The Compress® Segmental Humeral Replacement System Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal non-constrained or semi-

constrained porous-coated uncemented prosthesis

Regulatory Class: Class II

Product Code: MBF, KWS, KWT, JDC

Dated: May 08, 2012

Received: May 10, 2012

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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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#### Page 2 - Mr. Gary Baker, MS RAC

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Molkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation . Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Page 1 of 1

510(k) Number (if known):

Device Name: Compress Segmental Humeral Replacement System

Indications For Use:

The Compress® Segmental Humeral Replacement System is indicated for:

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

- 2. Tumor resections.
3. Revision of previously failed total joint arthroplasty.

4. Trauma.

The Compress® Segmental Humeral Replacement System components are intended for uncemented use.

The Discovery Elbow components when used in conjunction with the Compress® Segmental Humeral Replacement System are restricted to the Compress® Segmental Humeral Replacement System indications and are intended to be inserted with bone cement.

The Modular Hybrid Glenoid when used in conjunction with the Compress® Segmental Humeral Producement System is restricted to the Compress® Segmental Humeral Replacement System indications and is intended to be used with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

Prescription Use Yes (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ NO (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)

Antset

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112905