DEPUY TOTAL ELBOW SYSTEM

K992656 · DePuy Orthopaedics, Inc. · JDC · Nov 5, 1999 · Orthopedic

Device Facts

• Record ID: K992656
• Device Name: DEPUY TOTAL ELBOW SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: JDC · Orthopedic
• Decision Date: Nov 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy Total Elbow System is indicated to reduce pain and improve the function and mobility of the affected joint in patients with a painful arthritic joint due to osteoarthritis, rheumatoid arthritis, or post traumatic arthritis and pathological fractures of the distal humerus in which adequate bone stock exists for the fixation of prosthetic components. Total Elbow replacement may be considered for younger patients, if, in the opinion of the surgeon, an unequivocal indication for elbow replacement outweighs the risks associated with the age of the patient , and if limited demands regarding activity and elbow joint loading can be assured. This included patients for whom an immediate gain of elbow mobility may lead to an expectation of significant improvement in the quality of their lives. The DePuy Total Elbow System is intended for cemented use only.

Device Story

Total elbow prosthesis; implanted as unlinked (semi-constrained) or linked (constrained) system. Unlinked configuration relies on patient soft tissues (medial collateral ligament, triceps tendon) for stability; linked configuration uses ulnar component and pin assembly for support in cases of poor bone stock. Humeral stems (100, 150, 200mm) and ulnar stems (60, 80mm) provided to accommodate anatomy. Intended for cemented fixation. Used by orthopedic surgeons in clinical/surgical settings to restore joint function and reduce pain in patients with arthritis or fractures.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, materials, and performance standards.

Technological Characteristics

Elbow prosthesis system; humeral and ulnar stems of varying lengths. Materials and sterilization methods consistent with predicate devices. Cemented fixation required. Semi-constrained (unlinked) or constrained (linked) configurations.

Indications for Use

Indicated for patients with painful arthritic joints (osteoarthritis, rheumatoid arthritis, post-traumatic arthritis) or distal humerus pathological fractures requiring pain reduction and improved mobility. Requires adequate bone stock for fixation. Suitable for younger patients if surgeon determines benefits outweigh age-related risks and activity/loading demands are limited. Cemented use only.

Regulatory Classification

Identification

An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device 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,” (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,” (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,” (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 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• DePuy Mark II Elbow (K872084)
• Capitello-Condylar Total Elbow (K983141)

Submission Summary (Full Text)

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## K992656

NOV - 5 1999

# 510(k) Summary DePuy Total Elbow System

DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581

#### A. Contact Person:

Janet G. Johnson, RAC Senior Regulatory Associate [phone]

#### B. Device Information:

| Proprietary Name: | DePuy Total Elbow System |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Elbow Prosthesis |
| Classification: | When used as a semi-constrained (unlinked elbow), it<br>is a Class II device per 21 CFR §888.3160<br>When used as a constrained (linked), it is a Class III<br>device per 21 CFR §888.3150 |
| Product Code: | 87 JDB - Prosthesis, Elbow, Semi-Constrained,<br>Cemented (Class II)<br>87 JDC - Prosthesis, Elbow, Constrained, Cemented<br>(Class III) |

#### C. Indications for Use:

The DePuy Total Elbow System is indicated to reduce pain and improve the function and mobility of the affected joint in patients with a painful arthritic joint due to osteoarthritis, rheumatoid arthritis, or post traumatic arthritis and pathological fractures of the distal humerus in which adequate bone stock exists for the fixation of prosthetic components.

Total Elbow replacement may be considered for younger patients, if, in the opinion of the surgeon, an unequivocal indication for elbow replacement outweighs the risks associated with the age of the patient , and if limited demands regarding activity and elbow joint loading can be assured. This included patients for whom an immediate gain of elbow mobility may lead to an expectation of significant improvement in the quality of their lives.

The DePuy Total Elbow System is intended for cemented use only.

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### D. Device Description:

. . . . .

The DePuy Total Elbow System is designed to be implanted as either an unlinked (semiconstrained) or linked (constrained) elbow. When the DePuy Total Elbow System is implanted as an unlinked elbow it relies on existing soft tissues, such as the medial collateral ligament and triceps tendon for support and stability. While the linked system is held together with the linked ulnar component and pin assembly, and is used when there is poor bone stock.

The DePuy Total Elbow System humeral stems are available in 100, 150, and 200mm lengths. The ulnar stems available in two lengths 60 and 80mm lengths, right and left, to accommodate different patient anatomy. Both the humeral and ulnar stems are intended for use with bone cement.

#### E. Substantial Equivalence:

The substantial equivalence of the DePuy Total Elbow System is substantiated by its similarity in indications for use, design, materials, sterilization and packaging to the current DePuy Mark II Elbow (K872084) and the Capitello-Condylar Total Elbow (K983141).

The determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standards.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 1999

Janet G. Johnson, RAC Senior Regulatory Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K992656 Trade Name: DePuy Total Elbow System Regulatory Class: III Product Code: JDC and JDB Dated: August 6, 1999 Received: August 9, 1999

Dear Ms. Johnson:

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. ਸਿ 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.

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#### Page 2 - Janet G. Johnson, RAC

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,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

The DePuy Total Elbow System is indicated to reduce pain and improve the function and mobility of the affected joint in patients with a painful arthritic joint due to osteoarthritis, rheumatoid arthritis, or post traumatic arthritis and pathological fractures of the distal humerus in which adequate bone stock exists for the fixation of prosthetic components.

Total Elbow replacement may be considered for younger patients, if, in the opinion of the surgeon, an unequivocal indication for elbow replacement outweighs the risks associated with the age of the patient , and if limited demands regarding activity and elbow joint loading can be assured. This included patients for whom an immediate gain of elbow mobility may lead to an expectation of significant improvement in the quality of their lives.

The DePuy Total Elbow System is intended for cemented use only.

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division Division o eneral Roctor 510(k) Numbe

Prescription Use V (Per 21 CFR §801.109) OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)