KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY

K961260 · Biomet, Inc. · HSD · Apr 2, 1997 · Orthopedic

Device Facts

• Record ID: K961260
• Device Name: KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY
• Applicant: Biomet, Inc.
• Product Code: HSD · Orthopedic
• Decision Date: Apr 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1) Relief of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint. 2) Irreducible 3 and 4 part fractures of the proximal humerus. 3) Non-united or mal-united chronic humeral head fractures or fracture-dislocations. 4) Avascular necrosis of the humeral head. 5) Other difficult clinical management problems, including failed reconstructive procedures, where arthrodesis of resection arthroplasty are not considered acceptable.

Device Story

Shoulder prosthesis system; includes humeral stems (one-piece or modular) and modular glenoid metal backing. Substrate: Cobalt-Chromium-Molybdenum alloy. Surface modification: Titanium plasma spray coating. Design features: distally tapered stem with grooves for cement pressurization; proximal fins for rotational stability; continuous radius of curvature humeral head. Used by orthopedic surgeons in clinical settings for joint replacement. Replaces damaged humeral head/glenoid surfaces to relieve pain and restore function. Output: physical structural support for the glenohumeral joint.

Clinical Evidence

No clinical data provided; device relies on substantial equivalence to existing predicate devices.

Technological Characteristics

Substrate: Cobalt-Chromium-Molybdenum alloy. Coating: Titanium plasma spray. Design: Humeral stems (one-piece or modular) with Morse-type taper or screw thread attachments; modular glenoid metal backing with polyethylene bearing surface. Cemented fixation.

Indications for Use

Indicated for patients with severe pain or disability due to degenerative, rheumatoid, or traumatic glenohumeral joint disease; irreducible 3/4 part proximal humerus fractures; non-united/mal-united chronic humeral head fractures/dislocations; avascular necrosis; or failed prior reconstructive procedures.

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

• Kirschner II-C Humeral Stems (K873073)
• Modular II-C Humeral Stems (K874643)
• Atlas-C Modular Proximal Humeral Components (K940537)
• Modular Glenoid Metal Backing (K873104)

Submission Summary (Full Text)

{0}

BIOMET
CORPORATE HEADQUARTERS
K96 1260
APR - 2 1997

# Summary of Safety and Effectiveness

Sponsor: Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw, IN 46581-0578

Device: Kirschner Shoulders with Titanium Plasma Spray

Classification Name: Prosthesis, shoulder, non-constrained, metal/polymer cemented and Prosthesis, shoulder, humeral (hemi-shoulder) metallic

Indications for Use: 1) Relief of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint. 2) Irreducible 3 and 4 part fractures of the proximal humerus. 3) Non-united or mal-united chronic humeral head fractures or fracture-dislocations. 4) Avascular necrosis of the humeral head. 5) Other difficult clinical management problems, including failed reconstructive procedures, where arthrodesis of resection arthroplasty are not considered acceptable.

Device Description: The Kirschner Shoulders are all based on the original design concept of the Neer Shoulder. Common design features include Cobalt-Chromium-Molybdenum alloy substrate; smooth, distally tapered stem; grooves in the stem to aid in cement pressurization and provided torsional stability; four proximal fins to provided rotational stability and facilitate positioning during insertion; continuous radius of curvature humeral head geometry and; all humeral heads are compatible with all glenoid components. Kirschner II-C Humeral Stems are one piece in that the head and stem are an single component. Modular II-C Humeral Stems are a one piece stem with a modular head attached by a Morse-type taper. Atlas-C Modular Stems are two piece stems composed of a proximal humeral component and a distal stem attached by a screw thread. This component also utilizes a modular humeral head. The Modular Glenoid Metal Backing provides reinforcement to a polyethylene bearing surface. The design is identical to the predicate device.

This 510(k) is for a change from a cobalt alloy plasma spray coating to a titanium alloy coating and a change in the manufacturing location. All other aspects of the device remain the same.

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

SHIPPING ADDRESS
Airport Industrial Park
Warsaw, IN 46580

OFFICE
219.267.6639

FAX
219.267.8137

E-MAIL
[e-mail]

{1}

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 | Blood vessel damage | Bone fracture |
| --- | --- | --- |
| Deformity of the joint | Soft tissue imbalance | Infection |
| Cardiovascular disorders | Delayed wound healing | Hematoma |
| Fracture of the cement | Metal sensitivity | Dislocation |
| Implant loosening/migration | Fracture of the components | Excessive wear |
| Nerve damage | Disassociation of the modular head | |

Substantial Equivalence: In function and overall design, the Kirschner Shoulders with Titanium Plasma Spray are equivalent to almost all hip components on the market.

Devices are identical to the following predicate Kirschner products:
- Kirschner II-C Humeral Stems - K873073
- Modular II-C Humeral Stems - K874643
- Atlas-C Modular Proximal Humeral Components - K940537
- Modular Glenoid Metal Backing - K873104