BIO-MODULAR SHOULDER SYSTEM

K992119 · Biomet, Inc. · KWS · Sep 13, 1999 · Orthopedic

Device Facts

• Record ID: K992119
• Device Name: BIO-MODULAR SHOULDER SYSTEM
• Applicant: Biomet, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Sep 13, 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. Total shoulder replacement devices are intended to be inserted with bone cement. Non-porous coated humeral stems being implanted for hemi-arthroplasty may be press fit.

Device Story

Modular shoulder prosthesis system for partial or total shoulder arthroplasty; includes humeral stems, modular humeral heads, and glenoid components. Humeral stems feature bi-planer taper for stress transfer, lateral fin for rotational stability, and optional porous coating for cement fixation. Reverse Morse taper design places post on modular head and bore in stem, allowing glenoid exposure prior to stem implantation. Glenoid components include all-polyethylene (keeled or pegged) and metal-backed porous-coated options. Used by orthopedic surgeons in clinical settings. Provides structural replacement for damaged shoulder joints; restores function; addresses degenerative disease and fractures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Modular shoulder prosthesis. Materials: metal and polyethylene. Features: bi-planer taper humeral stems, reverse Morse taper head-stem interface, porous coating (plasma spray) or grit-blasted finish. Glenoid components: all-polyethylene (keeled or pegged) or metal-backed porous-coated. Fixation: cemented or press-fit. Sterilization: not specified.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, acute humeral head fractures unmanageable by other methods, cuff tear arthroplasty, 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

• Integrated Shoulder System (Kirschner)
• Gobal Shoulder (DePuy)
• Foundation Shoulder System (Encore Orthopedics)

Submission Summary (Full Text)

{0}------------------------------------------------

K992119

SEP 1 3 1999

Image /page/0/Picture/2 description: The image shows the logo for Biomet Inc. The logo consists of the word "BIOMET" in a stylized font, with the letters connected to each other. To the right of the word "BIOMET" is the word "INC." stacked vertically. Below the logo is the text "CORPORATE HEADQUARTERS".

## Summarv of Safetv and Effectiveness

Proprietary Name: Bio-Modular Shoulder System

## Classification Name:

- 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. Total shoulder replacement devices are intended to be inserted with bone cement. Non-porous coated humeral stems being implanted for hemi-arthroplasty may be press fit.

#### 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 arthroplasty

Device Description: The Bio-Modular Shoulder System consists of humeral stems of various lengths and porous coating levels, humeral heads of various diameters and neck lengths, and both all polyethylene and metal backed polyethylene glenoid components. Each type of component will be described individually.

| MAILING ADDRESS | P.O. Box 587<br>Warsaw, IN 46581 0587 |
|------------------|---------------------------------------------|
| SHIPPING ADDRESS | Airport Industrial Park<br>Warsaw, IN 46580 |
| OFFICE | 219.267.6639 |
| FAX | 219.267.8137 |
| E-Mail | [e-mail] |

000110

{1}------------------------------------------------

## K992119

- Humeral Stems: The Bio-Modular Humeral stem features a bi-planer taper to promote stress transfer down the length of the stem. This minimizes removal of endosteal bone and enhances the ease of stem insertion. Each stem has a lateral fin to provide rotational stability. Holes in the fin provide the surgeon with the option of suture attachment during fracture reconstruction. A collar minimizes subsidence. Stems are available in a primary lenath of 115mm in 1mm incremental stem diameters from 6 to 17mm. Longer stems (190mm) are available in 2mm incremental diameters from 7 to 13mm.
Humeral stems are available in either an Interlok (grit blasted) finish or with plasma spray porous coating. Porous stems are circumferentially porous coated proximally to enhance cement fixation. Centering sleeves are available to assist in stem alignment during cementina.

Humeral Heads: All humeral stems feature a reverse Morse taper for attachment of the modular humeral head. This means that instead of the tapered post being on the humeral stem like traditional devices, the post is on the modular head and the bore is in the stem. The advantage of the reverse taper configuration is that it allows for maximum exposure of the glenoid when the stem is in place. Therefore, the humeral stem may be implanted prior to glenoid resurfacing. Humeral heads are available in a variety of diameters and neck lengths. In addition to the standard symmetrical bearing surface, heads are available with articular extensions to enhance component stability.

Glenoid Components: Although the humeral stem and head may be implanted as a hemishoulder replacement, glenoid components are available for total shoulder replacement. All polyethylene alenoid components come in two styles. The keeled component features a triangular keel that may be trimmed for better fit during surgery. This style is available in 3 sizes and 2 thicknesses. The second style features 3 pegs to assist in fixation and is available in 3 sizes and 1 thickness. Both styles have an embedded x-ray marker.

A modular, porous coated, metal backed glenoid component provides distribution of stresses into the cement. The device features a central tapered peq and the option of screw fixation.

## Substantial Equivalence

Bio-Modular Shoulder (Biomet, Inc.) Integrated Shoulder System (Kirschner) Gobal Shoulder (DePuy) Foundation Shoulder System (Encore Orthopedics)

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing segments.

Public Health Service

SEP 1 3 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K992119

Trade Name: Bio-Modular Shoulder System Regulatory Class: III Product Code: KWS and HSD Dated: June 21, 1999 Received: June 23, 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 enclosure) 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 (QS) 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.

{3}------------------------------------------------

## 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

Enclosure

{4}------------------------------------------------

# 510(k) Number (if known): K992)19

Device Name: Bio-Modular Shoulder System

#### 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 arthroplasty

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992119

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)