MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM

K000335 · Biomet, Inc. · LPH · Feb 25, 2000 · Orthopedic

Device Facts

• Record ID: K000335
• Device Name: MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM
• Applicant: Biomet, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Feb 25, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) treatment of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; 5) revision of previously failed total hip arthroplasty due to recurrent dislocations.

Device Story

Modular total hip system; consists of proximal body and distal stem joined by Morse locking taper. Modification involves roller-hardened/machined process applied to male portion of Morse locking taper on distal stem. Device components made of same materials and finishes as predicate; interchangeable with existing Biomet modular hip stems. Used by orthopedic surgeons in clinical settings for hip arthroplasty. Provides structural support and articulation for hip joint; restores joint function; addresses degenerative disease or fracture. Output is physical implant assembly; aids clinical decision-making by providing stable prosthetic replacement for damaged femoral bone.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Modular hip prosthesis; metal/polymer construction. Features Morse locking taper junction. Distal stem modified via roller-hardened/machined process. Class II device (888.3358, 888.3350).

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal femur fractures (nonunion, femoral neck, trochanteric with head involvement), or revision of failed total hip arthroplasty due to recurrent dislocations.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Mallory-Head Modular Calcar (K000335)

Submission Summary (Full Text)

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K000335

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## SUMMARY OF SAFETY AND EFFECTIVENESS

Biomet, Inc. Sponsor:

Biomet Manufacturing, Inc. Manufacturer: Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587

Proprietary Name: Mallory-Head Modular Calcar Total Hip

Common or Usual Name: Metallic total hip system

Classification Name: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (888.3358); Prosthesis, hip, semi-constrained, metal/polymer, Cemented (888.3350)

Device Classification: Class II

Device Product Code: 87LPH; 87JDI

Device Description: The predicate Mallory-Head Modular Calcar was originally Device Deseription. The presented use. The distal stem has been modified by encared in 10-15-15 110 read/machined process to the male portion of the Morse applying a ron nardened massimal and distal portions of the stem. The prodicate locking taper that joins are pade of the same and have the same surface finishes and indications for use as well as the same lengths and configurations. These and indications for ass are interchangeable with all of Biomet's modular hip modified distal blems are liters. the proximal body and the distal stem are joined by means of a Morse locking taper.

Indications For Use: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, trochanterie fractures of the provision of previously failed total hip arthroplasty due to recurrent dislocations.

## Potential Risks:

- 1) Material sensitivity reactions. Implantation of foreign material in tissues can result in histological reactions involving various sizes of macrophages and fibroblasts. The clinical significance of this effect is uncertain, as similar changes may occur as a precursor to or during the healing process. Particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid. It has been reported that wear debris may initiate cellular response resulting in osteolysis or osteolysis may be a result of loosening of the implant.
- 2) Early or late postoperative, infection, and allergic reaction.

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K000335

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- 3) Intraoperative bone perforation or fracture may occur, particularly in the presence of poor bone stock caused by osteoporosis, bone defects from previous surgery, bone resorption, or while inserting the device.
- 4) Loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.
- 5) Periarticular calcification or osseification, with or without impediment of joint mobility.
- 6) Inadequate range of motion due to improper selection or positioning of components.
- 7) Undesirable shortening of limb.
- 8) Dislocation and subluxation due to inadequate fixation and improper positioning. Muscle and fibrous tissue laxity can also contribute to these conditions.
- 9) Fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.
- 10) Fretting and crevice corrosion can occur at interfaces between components.
- 11) Wear and/or deformation of articulating surfaces.
- 12) Trochanteric avulsion or non-unio1: as a result of excess muscular tension, early weight bearing or inadequate reattachment.
- 13) Problems of the knee or ankle of the affected limb or contralateral limb aggravated by leg length discrepancy, too much femoral medialization or muscle deficiencies.
- 14) Postoperative bone fracture and pain.

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FEB 2 5 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Fred McClure Regulatory Specialist Biomet Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K000335

Trade Name: Mallory-Head Modular Calcar Total Hip with Roller-Hardened/Machined Tapers Regulatory Class: II Product Code: LPH and JDI Dated: January 27, 2000 Received: February 3, 2000

Dear Mr. McClure:

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 legally marketed predicate 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 requirements, 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 – Mr. Fred McClure

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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Ternell Jaja

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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510 (k) Number (if known) : _

Mallory-Head Modular Calcar Total Hip Device Name:

Indications For Use: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) treatment of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; 5) revision of previously failed total hip arthroplasty due to recurrent dislocations.

K000335

Russell Rogers

(Division Sign-Off) (Division Sign-Only
Devision of General Restorative Device 5 | O(k) Number

**Prescription Use**
(Per 21 CFR 801.109)

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