COMPRESS ANTI-ROTATION SPINDLES

K101475 · Biomet Manufacturing Corp · KWA · Jun 18, 2010 · Orthopedic

Device Facts

• Record ID: K101475
• Device Name: COMPRESS ANTI-ROTATION SPINDLES
• Applicant: Biomet Manufacturing Corp
• Product Code: KWA · Orthopedic
• Decision Date: Jun 18, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Compress® Segmental Femoral Replacement System is indicated for: 1. Correction of 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 Femoral Replacement System components are intended for uncemented use.

Device Story

Compress® Segmental Anti-Rotation Spindles are orthopedic fixation components used to secure segmental joint replacements to host bone. Device utilizes spring-enhanced, stress-sharing design to generate compressive force on host bone, preventing atrophy and promoting bone growth. System consists of anchor plug, spindle, and femoral component. Modifications include addition of holes to spindle collar for pin placement to prevent rotation during initial post-implantation weeks, plus additional size options. Used in conjunction with knee or hip implants. Operated by orthopedic surgeons in clinical/surgical settings. Output is mechanical fixation of prosthetic components to bone, facilitating structural stability and patient mobility.

Clinical Evidence

No clinical data provided. Substantial equivalence based on mechanical bench testing and engineering analysis.

Technological Characteristics

Spring-enhanced, stress-sharing segmental fixation system. Components include anchor plugs and spindles. Features added anti-rotation pin holes and varied sizing. Uncemented application. Mechanical design focuses on rotational torque resistance.

Indications for Use

Indicated for patients requiring correction of failed osteotomy, arthrodesis, or previous joint replacement; tumor resections; revision of failed total joint arthroplasty; or trauma. Intended for uncemented use.

Regulatory Classification

Identification

A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).

Predicate Devices

• Compress® Segmental Femoral Replacement System (Short Spindle and Anchor Plugs) (K062998)
• Compress® Segmental Femoral Replacement System (K043547)

Submission Summary (Full Text)

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# 101475

Image /page/0/Picture/1 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in a stylized font with each letter enclosed in a box. The words "MANUFACTURING CORP." are printed in a simple sans-serif font below the logo.

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### 510(k) Summary

| Preparation Date: | 6/16/10 | |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Applicant/Sponsor: | Biomet Manufacturing Corp.<br>56 East Bell Drive<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587 | JUN 1 8 2010 |
| Contact Person: | Patricia Sandborn Beres<br>Senior Regulatory Specialist | |
| Proprietary Name: | Compress® Segmental Anti-Rotation Spindles | |
| Common Name: | Segmental Femoral Stem Component | |
| Classification Name: | JDL, Hip joint metal/metal semi-constrained, with a cemented acetabular<br>component, prosthesis (21 CFR §888.3320)<br>KWA, Hip joint metal/metal semi-constrained, with an uncemented<br>acetabular component, prosthesis (21 CFR §888.3330)<br>Hip Joint, Metal/Polymer, Semi-Constrained, Cemented Prosthesis<br>(21 CFR §888.3350)<br>Knee Joint, Femorotibial, Metal/Polymer Constrained, Cemented Prosthesis<br>(21 CFR §888.3510) | |
| | The compatible components included in this submission have the following<br>classifications: | |
| Subsequent Product Codes: | JDI, Hip Joint, Metal/Polymer, Semi-Constrained, Cemented Prosthesis<br>(21 CFR §888.3350)<br>KRO, Knee joint femorotibial metal/polymer constrained cemented<br>prosthesis (21 CFR §888.3510)<br>KWY, Hip joint femoral (hemi-hip) metal/polymer cemented or<br>uncemented prosthesis (21 CFR §888.3390)<br>KWZ, Hip joint metal/polymer constrained cemented or uncemented<br>prosthesis (21 CFR §888.3310)<br>LPH, Hip joint metal/polymer/metal semi-constrained porous-coated<br>uncemented prosthesis (21 CFR §888.3358)<br>LZO, Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis (21 CFR §888.3353)<br>LZY, Hip joint (hemi-hip) acetabular metal cemented prosthesis (21 CFR<br>§888.3370)<br>MEH, Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis (21 CFR §888.3353) | |

Malling Addresse:
Profilian Birlingson
Profilian Birlings (1982) Posted on September 1992
Del Comments (1982) Politics (1992)
Biografia (1992) Biografia (1972)
Status

Shipping Address!
56 East Bell Osse
Worsen, IN 46393

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Biomet Manufacturing Corp. Compress® Segmental Anti-Rotation Spindles Page 2 of 2

# Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Compress® Segmental Femoral Replacement System (Short Spindle and Anchor Plugs) - K062998 Compress® Segmental Femoral Replacement System - K043547

Device Description: The Compress® Seqmental Anti-Rotation Spindles are not joint replacements but rather a method of fixing a segmental joint replacement to the patient's host bone. It utilizes the same spring-enhanced, stress-sharing design as the predicate Compress® Segmental Femoral Replacement System to generate stress on the host bone which helps prevent bone atrophy and promotes bone growth. It is intended to be used in conjunction with a knee or hip implant.

The complete device consists of an anchor plug, a spindle and either a proximal or distal femoral component. This 510(k) addresses modifications to the spindles. Holes are being added to the collar of the spindles to allow placement of pins to prevent rotation of the initial weeks following implantation. Additional sizes of spindles are also being added to the line.

Intended Use: The Compress® Segmental Femoral Replacement System is indicated for:

- 1. Correction of 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 Femoral Replacement System components are intended for uncemented use.

Summary of Technologies: The Compress® Seqmental Anti-Rotation Spindles incorporate the same technology as the predicate devices.

Non-Clinical Testing: Mechanical testing (resistance to rotational torque) and engineering analyses (greater wall thickness, smaller pin holes) of the Compress® Segmental Anti-Rotation Spindles demonstrated that the device will functional within its intended use compared to the predicate device.

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

Biomet Manufacturing Corporation % Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 East Bell Drive, P.O. Box 587 Warsaw, Indiana 46581-0587

JUN 1 8 2010

Re: K101475 Trade/Device Name: Compress® Segmental Anti-Rotation Spindles Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Codes: KWA, JDL, KRO, KWZ, JDI, LZO, MEH, LPH, KWY Dated: May 26, 2010 Received: May 28, 2010

Dear Ms. Beres:

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. Iisting 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.

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

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#### Page 2 - Ms. Patricia Sandborn

CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

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/CDRH0ffices/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/ReportalProblem/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,

Sincerely yours,

Barbara buel

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

510(k) Number (if known): K101475

Device Name: Compress® Segmental Anti-Rotation Spindles

#### Indications for Use:

The Compress® Segmental Femoral Replacement System is indicated for:

- 1. Correction of 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 Femoral Replacement System components are intended for uncemented use.

Prescription Use × (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)

Jouetu for mxm

. Prision Sign-Division of Surgical, Orthopedia, and Restorative Devices

510(k) Number K101475

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