ACCOLADE C FEMORAL COMPONENT

K002320 · Howmedica Osteonics Corp. · LZO · Sep 14, 2000 · Orthopedic

Device Facts

• Record ID: K002320
• Device Name: ACCOLADE C FEMORAL COMPONENT
• Applicant: Howmedica Osteonics Corp.
• Product Code: LZO · Orthopedic
• Decision Date: Sep 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Accolade™ C Femoral Component is intended for the reconstruction of the head and neck of the femoral joint and is intended for implantation with bone cement.

Device Story

Accolade™ C Femoral Component is a neutral, collared femoral stem used in total hip arthroplasty. Device is implanted with bone cement to reconstruct the femoral head and neck. Available in multiple sizes with 127° or 132° neck angles. Compatible with Howmedica Osteonics acetabular components, unipolar/bipolar components, and V40™ femoral heads (5° 40′ BG taper). Includes optional distal spacer. Used by orthopedic surgeons in clinical settings. Provides structural support for hip joint, restoring function and mobility in patients with degenerative joint disease or fractures.

Clinical Evidence

Bench testing only. Evidence includes finite element analysis demonstrating neck strength equal to or exceeding values proposed by Semlitsch et al., and body strength testing of the smallest stem size per ISO 7206-8 performance criteria.

Technological Characteristics

Material: Forged cobalt-chromium-molybdenum alloy (ASTM F 799). Distal spacer: Polymethylmethacrylate (PMMA) with BaSO4. Design: Neutral, collared femoral stem with 127° or 132° neck options. Interface: 5° 40′ BG taper for femoral head mating. Fixation: Cemented.

Indications for Use

Indicated for cemented primary hip surgery in patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, rheumatoid arthritis), functional deformity, nonunion, or proximal femoral fractures (neck/trochanteric) with head involvement unmanageable by other techniques. Also indicated for revision procedures.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Howmedica® DRG Femoral Component (K936126)
• Howmedica® Premium Femoral Component (K936127)
• Osteonics® Omnifit® EON™ Hip System (K933561)
• Ranawat/Burstein Total Hip Femoral Component (K911685)

Submission Summary (Full Text)

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## SEP 1 4 2000

#### 510(k) Summarv

#### Device: Accolade™ C Femoral Component

The Accolade™ C Femoral Component is a neutral, collared femoral stem and is available in a range of sizes to fit varying anatomical requirements. This device is available in two neck angle options, 127° and 132°, for each corresponding body geometry. A distal spacer is offered for use with this femoral component and is offered in various sizes.

This femoral component is intended for the reconstruction of the head and neck of the femoral joint and is intended for implantation with bone cement. The Accolade™ C Femoral Component can be used in conjunction with any currently available Howmedica Osteonics acetabular components, unipolar and bipolar components and Howmedica Osteonics V40™ femoral heads that can be mated with a 5° 40′ BG taper.

The Accolade™ C Femoral Component is indicated for cemented primary hip surgery in cases of noninflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. Additionally, this femoral stem can be used in the treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. This stem is also indicated for use in revision procedures where other treatments or devices have failed.

The Accolade™ C Femoral Component is fabricated from forged cobalt-chromium-molybdenum alloy which complies to ASTM standard F 799. The distal spacer is manufactured from polymethylmethacrylate (PMMA) with BaSO4.

Finite element analysis of this femoral stem indicates the neck strength equals or exceeds the value proposed by Semlitsch, et. al. Body strength of the smallest size stem meets the performance criteria outlined in ISO 7206-8.

The substantial equivalence of the Accolade™ C Femoral Component is based upon equivalence in intended use, materials, design, and operational principles to the Howmedica® DRG Femoral Component (Howmedica Osteonics Corp.; K936126), Howmedica® Premium Femoral Component (Howmedica Osteonics Corp.; K936127), Osteonics® Omnifit® EON™ Hip System (Howmedica Osteonics Corp.; K933561) and Ranawat/Burstein Total Hip Femoral Component (Biomet®; K911685).

For information contact:

Ms. Nancy J. Rieder Rutherford Regulatory Affairs Howmedica Osteonics Corp. 359 Veterans Boulevard Rutherford, New Jersey 07070-2584 Telephone: [phone] Fax: [phone] E-mail: [e-mail]

Summary Date: July 28, 2000

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# SEP 1 4 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Nancy J. Rieder Rutherford Regulatory Affairs Howmedica Osteonics Corp. 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

Re: K002320

Trade Name: Accolade C Femoral Component Regulatory Class: II Product Code: LZO Dated: July 28, 2000 Received: July 31, 2000 Amended: September 11, 2000

Dear Ms. Rieder:

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 control provisions of the Act. The general control 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 HI (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.

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.

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### Page 2 - Ms. Nancy J. Rieder

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and if you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the Office additionally 809.10 for in vito diagnostions on the promotion and advertising of your device, [phone]. Additionally, for questions on are peaces on the regulation please contact the Office of Comphance at (301) 377 - Testion' (21) CFF 807.97). Other general entitled, "Misbranding by relective of pening the Act may be obtained from the Division of Small
information on your responsibilities under the 1000 (2000) 443, 6507, or at i information on your responsionnites under [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Dune R. Lechner

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Accolade™ C Femoral Component

Indications for Use:

The Accolade™ C Femoral Component is indicated for cemented primary hip surgery in cases of non-inflammatory degenerative ioint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. Additionally; this femoral stem can be used in the treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. This stem is also indicated for use in revision procedures where other treatments or devices have failed.

The Accolade™ C Femoral Component is intended for implantation with bone cement.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X OR (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Duane P. Vochines

(Division Sign-Off) Civision of General Restorative Devices

510(k) Number LOOZ320