BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS

K992899 · Biomet, Inc. · KWS · Oct 21, 1999 · Orthopedic

Device Facts

• Record ID: K992899
• Device Name: BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS
• Applicant: Biomet, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Oct 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Bio-Modular Shoulder System is intended for partial or total shoulder ioint arthroplasty.

Device Story

Bio-Modular Shoulder Offset Humeral Heads are modular orthopedic implants for shoulder arthroplasty. Device features 5-degree offset stem relative to head center to increase bearing surface area; enables reconstruction of natural shoulder anatomy; potentially reduces dislocation risk. Surgeon uses provided alignment pin to index head orientation against humeral stem via 8-hole interface. Used in clinical/surgical settings by orthopedic surgeons. Output is physical restoration of joint geometry. Benefits include improved anatomical fit and stability compared to centered modular heads.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Cobalt alloy (Co-Cr-Mo) per ASTM F-1537. Modular humeral head with 5-degree offset stem. Alignment pin and 8-hole indexing system for orientation. Mechanical prosthesis for surgical implantation.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, cuff tear arthropathy, acute humeral head fractures unmanageable by other methods, or revision cases where prior treatments failed.

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 Shoulder System (K87245)
• Aequalis Shoulder Prosthesis (K95292)
• Global Dialable Eccentric Head (K97404)

Submission Summary (Full Text)

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K992899

Image /page/0/Picture/1 description: The image shows the logo for Biomet INC. The logo is in black and white and features the company name in a bold, sans-serif font. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller font.

## Summary of Safety and Effectiveness

Device Name: Bio-Modular Shoulder Offset Humeral Heads

#### Classification Name:

OCT 21 1999

- 1) Shoulder joint metal/polymer semi-constrained cemented prosthesis (Section 888.3660)
- 2) Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis (Section 888.3690)

## Device Classification and Product Codes:

- 1) Pre-amendment Class III (proposed reclassification to class II, published March 15, 1999) KWS
- 2) Class II HSD

Intended Use: The Bio-Modular Shoulder System is intended for partial or total shoulder ioint arthroplasty.

#### Indications for use:

- 1) Non-inflammatory 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) Treatment of acute fracture of the humeral head unmanageable using other treatment methods.
- 6) Cuff tear arthropathy

Device Description: Offset Humeral Heads are a modification of standard modular heads. Rather than a modular head with a centered stem providing the same amount of bearing surface circumferentially from the stem, the stem is place 5 degrees off the center point of the head providing a greater amount of bearing surface. This gives the surgeon the ability to more closely reconstruct the natural anatomy of the patient's shoulder and potentially reduce the risk of dislocation. In order to replicate trial orientation of the Offset Humeral Head, an alignment pin is provided which fits into a hole in the humeral stem and then may be aligned with on of 8 holes on the under surface of the head. The Bio-Modular Offset Humeral Heads are manufactured from cobalt alloy (Co-Cr-Mo) conforming to ASTM F-1537.

SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580

E-MAIL [e-mail]

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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 the bone cement Deformity of the joint Cardiovascular disorders Fracture of the cement Implant loosening/migration Nerve damage

Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the components Disassociation of the modular head

Bone fracture Infection Hematoma Dislocation Excessive wear

Substantial Equivalence: Biomet's Bio-Modular Shoulder Offset Humeral Heads are substantially equivalent to other shoulder devices on the market. Specifically, the device may be compared to :

| Bio-Modular Shoulder System (Biomet, Inc.) | 510(k) K87245- |
|----------------------------------------------|----------------|
| Aequalis Shoulder Prosthesis (Tornier, Inc.) | 510(k) K95292- |
| Global Dialable Eccentric Head (DePuy) | 510(k) K97404- |

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Image /page/2/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 wing segments, facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1999

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc. P. O. Box 587 Warsaw, Indiana 46581-0587

K992899 Re:

> Trade Name: Bio-Modular Offset Humeral Heads Regulatory Class: III Product Code: KWS and HSD Dated: August 26, 1999 Received: August 30, 1999

Dear Ms. Beres:

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 enclosures) 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, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 regulation may result in regulatory 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.

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### Page 2 - Ms. Patricia Sandborn Beres

This letter will allow you to begin marketing your device as described in your 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 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" (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,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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# 510(k) Number (if known): K992899

#### Device Name: Bio-Modular Shoulder Offset Humeral Heads

#### Indications For Use:

'

- joint disease including 1) Non-inflammatory degenerative osteoarthritis and avascular necrosis.
- Rheumatoid arthritis 2)
- Revision where other devices or treatments have failed 3)
- Correction of functional deformity 4)
- Treatment of acute fracture of the humeral head unmanageable using 5) other treatment methods.
- Cuff tear arthropathy ୧)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDBO)

. Concurrence of CDRH, Office of Device Evaluation (C

(ODE)

(Division Sign-Off) Division of General Restorative Devi 510(k) Number

Prescription Use_ V (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)