COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE

K033506 · Biomet, Inc. · KWS · Feb 2, 2004 · Orthopedic

Device Facts

• Record ID: K033506
• Device Name: COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE
• Applicant: Biomet, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Feb 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Comprehensive Humeral Fracture Positioning Sleeve is indicated for 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Revision where other devices or treatments have failed; 4) Correction of functional deformity; 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate; and 6) Difficult clinical management problems, including cuff arthopathy, where other methods of treatment may not be suitable or may be inadequate.

Device Story

Comprehensive Humeral Fracture Positioning Sleeve is a PMMA accessory for the Comprehensive Humeral Fracture System (K023063). Device fits over distal tapered stem of fracture system; stops below stem fins. Function: centers stem within humeral canal; allows vertical adjustment of stem position. Used in orthopedic surgery; operated by surgeons. Provides mechanical stabilization of humeral prosthesis during cemented implantation. Benefits patient by ensuring proper alignment and positioning of humeral fracture implant.

Clinical Evidence

No clinical data provided. Substantial equivalence based on engineering justification and comparison to predicate devices.

Technological Characteristics

Material: Polymethyimethacrylate (PMMA). Form factor: Sleeve designed to fit over distal tapered stem of humeral fracture system. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal humerus fractures, or cuff arthropathy requiring revision or where other treatments are inadequate. For cemented use only.

Regulatory Classification

Identification

A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Special Controls

*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,” (vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• Bio-Modular Centering Sleeve (K032507)
• Comprehensive Humeral Fracture Stem (K023063)

Submission Summary (Full Text)

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FEB - 2. 2004

K03366

BIOMET

#### 510(k) Summary

| Applicant/Sponsor: | Biomet Manufacturing Corp. |
|--------------------|---------------------------------------------------|
| Contact Person: | Tracy J. Bickel<br>Regulatory Associate |
| Proprietary Name: | Comprehensive Humeral Fracture Positioning Sleeve |
| Common Name: | Centering Sleeve |

Classification Name:

- Prosthesis, shoulder, non-constrained, metal/polymer cemented prosthesis (888.3650) .
- Shoulder joint metal/polymer semi-constrained cemented prosthesis (888.3660) .

### Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

- Bio-Modular Centering Sleeve (K032507): Biomet, Inc. ●
- Comprehensive Humeral Fracture Stem (K023063): Biomet, Inc. .

Device Description: The Comprehensive Humeral Fracture Positioning Sleeve is composed of Polymethyimethacrylate (PMMA) and is used in conjunction with the Comprehensive Humeral Fracture System (K023063). The device is a sleeve that fits over the distal tapered stem of the Comprehensive Fracture system and stops at a point below the fins of the stem.

Intended Use: The Comprehensive Humeral Fracture Positioning Sleeve is indicated for 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Revision where other devices or treatments have failed; 4) Correction of functional deformity; 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate; and 6) Difficult clinical management problems, including cuff arthopathy, where other methods of treatment may not be suitable or may be inadequate.

Summary of Technologies: The Comprehensive Humeral Fracture Positioning Sleeve is to be used in conjunction with the stem in the previously cleared Comprehensive Humeral Fracture System. The sleeve holds the stem in the center of the canal as well as allowing the sleeve and stem to be raised and lowered in the canal. The Comprehensive Humeral Fracture Positioning sleeve is similar to or identical in terms of material, function, labeling, and sizing to the predicate device(s).

Non-Clinical Testing: An engineering justification was utilized to determine that no additional mechanical testing was required.

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

All trademarks are property of Biomet, Inc.

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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 & Human Services. The logo features a stylized eagle with three horizontal lines above it, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tracy J. Bickel Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 45681-0587

FEB - 2 2004

#### Re: K033506

: Trade/Device Name: Comprehensive Humeral Fracture Positioning Sleeve Regulation Number: 21 CFR 888.3660; 888.3560

Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis; Shoulder joint mctal/polymer non-constrained cemented prosthesis

Regulatory Class: Class II Product Code: KWS, KWS, KWT Dated: November 4, 2003 Received: November 5, 2003

Dear Ms. Bickel:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your beermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreased of the enactment date of the Medical Device Amendments, or to commerce prox to rias 2013 uctions marce Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmette Ace, rece rear the device, subject to the general controls provisions of the Act. The 1 ou may, morelyre, mains of the Act include requirements for annual registration, listing of general controls provincias or vactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your device to such additional controls. Existing major regulations affecting your device can may be subject to back and Regulations, Title 21, Parts 800 to 898. In addition, FDA may oublish 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 that 1171 Has Intacted and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) rms teter withication. The FDA finding of substantial equivalence of your device to a legally

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Page 2 – Ms. Tracy J. Bickel

marketed predicate device 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), please If you uesn't specific advice 101 Jour as 1) 594-4659. Also, please note the regulation entitled, Colliact the Office of Comphanes at (Set notification" (21CFR Part 807.97). You may obtain Misolalion'ny by telefonoe to premains on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

[phone] of at its michieraals.ss
http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milliken

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

Enclosure

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## Indications for Use

## 510(k) Number (if known): K033506

# Device Name: Comprehensive Humeral Fracture Positioning Sleeve

### Indications For Use:

The Comprehensive Humeral Fracture Positioning Sleeve is indicated for

- omprehensive Pramorative joint disease including osteoarthritis and avascular necrosis;
- 2) Rheumatoid arthritis;
- 3) Revision where other devices or treatments have failed;
- 4) Correction of functional deformity;
- 4) Gorroclures of the proximal humerus, where other methods of treatment are deemed inadequate; and
- 6) Difficult clinical management problems, including cuff arthopathy, where other Difflour of treatment may not be suitable or may be inadequate.

For Cemented Use Only

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

Over-The-Counter Use (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)

Mark N Milheim

Childre

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