COPELAND MB/HA RESURFACING HUMERAL HEADS

K010827 · Biomet Orthopedics, Inc. · HSD · Sep 14, 2001 · Orthopedic

Device Facts

• Record ID: K010827
• Device Name: COPELAND MB/HA RESURFACING HUMERAL HEADS
• Applicant: Biomet Orthopedics, Inc.
• Product Code: HSD · Orthopedic
• Decision Date: Sep 14, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Copeland™ MB/HA Resurfacing Humeral Heads are indicated for the following conditions where the humeral head and neck are of sufficient bone stock and there is presence of an intact or reconstructable rotator cuff which is necessary for proper functioning and dislocation resistance: 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2) Rheumatoid arthritis 3) Correction of functional deformity 4) Reconstructable rotator cuff 5) Treatment of fractures of the humeral head 6) Traumatic arthritis For uncemented use only.

Device Story

Cementless humeral replacement system; requires minimal bone resection; preserves bone stock for potential future revision to longer-stemmed prosthesis. Components: cobalt-chrome-molybdenum alloy (ASTM F-75) humeral heads; available in four sizes (small, medium, large, extra-large). Surface features: MacroBond™ plasma spray coating on non-articulating surface; hydroxyapatite (HA) coating over MacroBond™. Used in hemi- or total shoulder replacement procedures; performed by surgeons in clinical settings. Small, medium, and large heads compatible with Biomet Bio-Modular® or Integrated Glenoids; extra-large head incompatible with Integrated Glenoids. Provides alternative to traditional total shoulder devices requiring greater bone removal; benefits patients by maintaining anatomical bone stock.

Clinical Evidence

Clinical data provided for 69 HA-coated resurfacing heads implanted since 1994. Minimum follow-up of 2 years. Results: zero revisions reported; no radiographic lucencies observed surrounding devices. Bench testing included Finite Element Analysis comparing subject device to predicate and mechanical characterization of the MacroBond™ coating.

Technological Characteristics

Materials: Cobalt-chrome-molybdenum alloy (ASTM F-75). Surface: MacroBond™ plasma spray coating with hydroxyapatite (HA) overlay. Design: Tapered, fluted stem; four sizes (S, M, L, XL). S, M, L share radius of curvature; XL has larger radius. Fixation: Uncemented. Sterilization: Not specified.

Indications for Use

Indicated for patients with sufficient humeral bone stock and intact/reconstructable rotator cuff requiring shoulder hemi- or total replacement due to osteoarthritis, avascular necrosis, rheumatoid arthritis, functional deformity, humeral head fractures, or traumatic arthritis.

Regulatory Classification

Identification

A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.

Predicate Devices

• Copeland M Resurfacing Heads (K003044)
• Bi-Polar Shoulder (K002998)
• Bi-Polar Shoulder System (K991585)
• Bio-Modular® Shoulder System (K992119)

Submission Summary (Full Text)

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K010827

## SEP 1 4 2001

## CORPORATE HEADQUARTERS SUMMARY OF SAFETY AND EFFECTIVENESS

| Sponsor: | Biomet, Inc.<br>Airport Industrial Park<br>Warsaw, Indiana 46580 |
|----------------------|--------------------------------------------------------------------|
| Contact Person: | Sara B. Shultz<br>Telephone: [phone]<br>Fax: [phone] |
| Device: | Copeland™ MB/HA Resurfacing Humeral Heads |
| Classification Name: | prosthesis, shoulder, hemi-, humeral, metallic,<br>uncemented |
| Device Product Code: | HSD (21 CFR 888.3690)<br>MBF (unknown, recently down classified) |

Legally Marketed Devices To Which Substantial Equivalence is Claimed: Copeland M Resurfacing Heads (K003044), Bi-Polar Shoulder (K002998), Bi-Polar Shoulder System (K991585), and Bio-Modular® Shoulder System (K992119).

Intended Use: The Copeland™ MB/HA Resurfacing Humeral Heads are indicated for the following conditions where the humeral head and neck are of sufficient bone stock and there is presence of an intact or reconstructable rotator cuff which is necessary for proper functioning and dislocation resistance:

- 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- 2) Rheumatoid arthritis
- 3) Correction of functional deformity
- 4) Reconstructable rotator cuff
- 5) Treatment of fractures of the humeral head
- 6) Traumatic arthritis

For uncemented use only.

Device Description: These devices are intended for use as a cementless fixation humeral replacement system that requires minimal bone resection. Copeland™ MB/HA Resurfacing Humeral Heads can be used in hemi- or total shoulder replacement surgical

> MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

SUPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639

万人彩 319.267.2137

E-MAIL [e-mail]

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Image /page/1/Picture/0 description: The image shows the logo for Biomet Corporate Headquarters. The word "BIOMET" is in a bold, sans-serif font, with the letters connected. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller, serif font.

procedures in patients experiencing pain and disability of the gleno-humeral joint. By preserving the boxe stock, this device gives a patient an alternative to other total shoulder devices where more bone is removed. This device can easily be revised to a longer stemmed prosthesis if necessary due to the initial bone preservation.

The humeral head components are available in four sizes - small, medium, large, and extra-large. The small, medium, and large humeral heads have the same radius of curvature, but the heights differ to cater for the range of anatomical sizes and offsets. The extra-large head has a larger radius of curvature to accommodate a patient with larger bone stock. The stem is tapered and fluted to provide maximum stability in the humerus. The components are manufactured from cobalt-chrome-molybdenum alloy (ASTM F-75) and have a thin layer of plasma spray coating known as MacroBond™ on the non-articulating surface. There is a depression in the surface of the inner spherical radius of the head. This depression is intended for the location of the MacroBond™ Coating. The MacroBond™ coated portion of the device is further coated with hydroxyapatite (HA).

The small, medium, and large humeral head components can be used with Biomet's Bio-Modular® Glenoids or Integrated Glenoids. The extra-large head can not be used with Integrated Glenoids due to the larger spherical radius.

Summary of Technologies: The Copeland™ MB/HA Resurfacing Humeral Heads have the same design as the predicate Copeland™ Resurfacing Heads. The predicate devices are porous coated and cleared for cemented use, whereas, this submission contains a device with a MacroBond™/HA coating indicated for uncemented use. Clinical data was supplied to address these differences.

Non-Clinical Testing: Finite Element Analysis was done to compare the Copeland™ MB/HA Resurfacing Humeral Heads to the predicate, CopelandIM Resurfacing Heads. The MacroBond™ coating was characterized by performing various mechanical tests.

Clinical Testing: Since 1994, sixty-nine HA coated resurfacing heads have been implanted in cementless surface replacement arthroplasty of the shoulder. The minimum follow-up was 2 years with no revisions reported. Radiographically, no lucencies were observed surrounding these devices. These clinical results provide information to demonstrate the substantial equivalence of the Copeland™ MB/HA Resurfacing Humeral Heads.

> MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639

FAX [phone]

E-MAIL ריוסט.biomet@ גרוסט

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 2001

Ms. Sara B. Shultz Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K010827/S001

Trade/Device Name: Copeland™ MB/HA Resurfacing Humeral Heads Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: June 14, 2001 Received: June 18, 2001

Dear Ms. Shultz:

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.

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

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Page 2 - Ms. Sara B. Shultz

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 and additionally 21 CFR Part 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 the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely vours.

Susan Walk, is

Image /page/3/Picture/5 description: The image shows a black and white close-up of a handwritten letter 'f'. The letter is written in a cursive style with a loop at the top and a curved line extending to the right. The letter is slightly tilted to the left and appears to be written with a thick marker or pen.

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

Enclosure

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## -Page 1 of 1

510 (k) Number (if known) : __ KO\0827

Device Name: Copeland™ MB/HA Resurfacing Humeral Heads

Indications For Use:

The Copeland™ MB/HA Resurfacing Humeral Heads are indicated for the following The Coperation - HD/11111111111111111111111111111111111111111111111111111111111 presence of an intact or reconstructable rotator cuff which is necessary for proper functioning and dislocation resistance:

- 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- 2) Rheumatoid arthritis
- 3) Correction of functional deformity
- 4) Reconstructable rotator cuff
- 5) Treatment of fractures of the humeral head
- 6) Traumatic arthritis

For uncemented use only.

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:left;"> OR Over-The-Counter-Use<br/> (Optional Format 1-2-96) </div> |

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
00003

| 510(k) Number | # K010827 |
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|---------------|-----------|