SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS

K971715 · Sulzer Orthopedics, Inc. · KWS · Aug 7, 1997 · Orthopedic

Device Facts

• Record ID: K971715
• Device Name: SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS
• Applicant: Sulzer Orthopedics, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Aug 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Select Shoulder Offset Humeral Heads, when used with one of the Select Shoulder Humeral Stems and Glenoid Components (if applicable), are intended for use in treatment of the following: 1. Patient conditions, including but not limited to, noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis or post-traumatic arthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. 2. Complex acute fractures, fracture-dislocations of the humeral head, malunion or non-union of a small osteoporotic head fragment, chronic, recurrent or acute dislocation with loss of humeral head cartilage, or large impression fractures. 3. Those patients with failed previous surgery where pain, deformity, or dysfunction persists. 4. Failed previous surgery, including joint reconstruction, internal fixation, nonunion of the humeral neck, arthrodesis or hemiarthroplasty. 5. Cuff tear arthropathy. 6. Avascular necrosis or osteonecrosis of the humeral head. 7. Tumor resection.

Device Story

Select Shoulder Offset Humeral Heads are metallic orthopedic implants manufactured from cobalt chrome alloy (CoCrMo). Designed for articulation with human glenoid or all-poly glenoid components; features female taper for attachment to Select Shoulder humeral stems. Underside includes clock-like numbering (1-12) for surgeon reference to select head position relative to glenoid. Offset taper location facilitates insertion, anatomic soft tissue balancing, and improved glenoid contact. Used by orthopedic surgeons in clinical settings for shoulder arthroplasty. Device provides structural replacement of humeral head to restore joint function, reduce pain, and improve stability in patients with degenerative or traumatic shoulder conditions.

Clinical Evidence

Bench testing only. Testing included pulloff strength measurements and contact area analysis at various levels of abduction to verify mechanical performance and joint contact characteristics compared to predicate devices.

Technological Characteristics

Metallic humeral head component; material: cobalt chrome alloy (CoCrMo). Features female taper for modular attachment to humeral stems. Articulating surface is polished; underside may be polished or grit blasted. Includes clock-like numbering (1-12) for orientation. Available in various heights and diameters.

Indications for Use

Indicated for patients requiring shoulder joint replacement due to noninflammatory degenerative joint disease (osteoarthritis, post-traumatic arthritis), inflammatory joint disease (rheumatoid arthritis), complex acute fractures, fracture-dislocations, malunion/non-union, chronic/recurrent dislocation, cuff tear arthropathy, avascular necrosis, or tumor resection.

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

• Tornier Aequalis Shoulder System
• Depuy Global Total Shoulder System
• Biomet Bio-Modular Total Shoulder
• Zimmer Fenlin Total Shoulder
• Kirschner Modular Shoulder System
• 3M/Orthomet Modular Neer II Shoulder System
• Encore Foundation Shoulder System

Submission Summary (Full Text)

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## 510(k) SUMMARY

April 29, 1997

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Sulzer Orthopedics Inc. Select® Shoulder Offset Humeral Heads.

| Submitter: | Sulzer Orthopedics Inc.<br>9900 Spectrum Drive<br>Austin, TX 78717<br>[phone] |
|----------------------|--------------------------------------------------------------------------------------|
| Contact Person: | Jacquelyn Hughes<br>Manager, Regulatory Affairs |
| Classification Name: | No formal classification has been established for humeral head<br>components. |
| Common/Usual Name: | Humeral Head Components |
| Trade/Proprietary: | Select® Shoulder Offset Humeral Heads |

## Product Description/Substantial Equivalence:

The Select Shoulder Offset Humeral Heads are metallic components manufactured from cobalt chrome alloy (CoCrMo). The heads, once impacted onto one of the Select Shoulder humeral stems, are designed to articulate with the normal human glenoid or with a replacement all-poly glenoid component. The humeral heads feature a female taper which allows for attachment to the male taper of the Sulzer Orthopedics Select Shoulder Humeral Stems. The articulating surface of the head is polished. The underside of the head, with the exception of the taper attachment feature, may be either polished or grit blasted. Similar to the face of a clock, the underside of the head is numbered from 1-12, giving the surgeon the ability to reference and select the position of the head relative to the glenoid. The location of the female taper is offset from center, thus permitting ease of insertion into the joint, allowing closer replication of the normal head anatomy permitting accurate anatomic soft tissue balancing, and providing greater contact with the glenoid when the humerus is in a normal resting position. The heads are available in a variety of heights and diameters. The humeral heads are designed for use with Sulzer Orthopedics Humeral Stems and/or glenoid components which come in a variety of sizes for increased stability of the glenohumeral joint.

Testing indicated that the pulloff strengths for the Select Shoulder Offset Humeral Heads were comparable to currently marketed devices. Contact area testing indicated that the offset heads provide adequate contact area at various levels of abduction.

The Select Shoulder CoCr Humeral Heads are similar to those of the Tornier Aequalis Shoulder System, the Depuy Global Total Shoulder System, the Biomet Bio-Modular Total Shoulder, the Zimmer Fenlin Total Shoulder, the Kirschner Modular Shoulder System, the 3M/Orthomet Modular Neer II Shoulder System, and the Encore Foundation Shoulder System.

## UUUZZA

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mitchell A. Dhority, RAC Senior Regulatory Affairs Specialist ---------SulzerMedica ¨ Sulzer Orthopedics, Inc. AUG - 7 1997 9900 Spectrum Drive Austin, Texas 78717

Re : K971715 Trade Name: Select Shoulder Offset Humeral Heads Regulatory Class: III Product Codes: KWS, KWT, and HSD Dated: May 7, 1997 Received: May 9, 1997

Dear Mr. Dhority:

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 requlation (21 CFR Part 820) and that,

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Page 2 - Mitchell A. Dhority, RAC

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 In addition, FDA may publish further announcements action. 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 requlations.

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 yitro 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,

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

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Select Shoulder Offset

Device Name: Humeral Heads

Indications for Use:

The Select Shoulder Offset Humeral Heads, when used with one of the Select Shoulder Humeral Stems and Glenoid Components (if applicable), are intended for use in treatment of the following: ... .. . ...........

- Patient conditions, including but not limited to, noninflammatory degenerative joint 1. disease (NIDJD), e.g., osteoarthritis or post-traumatic arthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- Complex acute fractures, fracture-dislocations of the humeral head, malunion or non-2. union of a small osteoporotic head fragment, chronic, recurrent or acute dislocation with loss of humeral head cartilage, or large impression fractures.
- Those patients with failed previous surgery where pain, deformity, or dysfunction 3. persists.
- Failed previous surgery, including joint reconstruction, internal fixation, nonunion of 4. the humeral neck, arthrodesis or hemiarthroplasty.
- Cuff tear arthropathy. న.
- Avascular necrosis or osteonecrosis of the humeral head. 6.
- 7. Tumor resection.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

evice Evaluation (ODE)

(Division Sign-Off)
Division of Genarai Restorative Devices
510(%) Numbar. K971715

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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