TAPER 2 POROUS FEMORAL STEM

K050441 · Biomet, Inc. · JDI · Jun 29, 2005 · Orthopedic

Device Facts

• Record ID: K050441
• Device Name: TAPER 2 POROUS FEMORAL STEM
• Applicant: Biomet, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Jun 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Taper 2™ Porous Femoral Stem is indicated for use in patients requiring total hip replacement due to the following: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques; Revision of previously failed femoral head resurfacing component. Taper 2™ Porous Femoral Stems are intended for uncemented use only.

Device Story

Taper 2™ Porous Femoral Stem is a short, tapered femoral component for total hip arthroplasty. Device is implanted into the femur during hip replacement surgery to restore joint function. It is designed for uncemented fixation. The stem is used in conjunction with modular heads and acetabular components. It is intended for use by orthopedic surgeons in a clinical/hospital setting. The device provides structural support and stability for the hip joint, aiming to alleviate pain and restore mobility in patients with degenerative joint disease, arthritis, or fractures. Clinical benefit is derived from the restoration of hip joint function and stability.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and reference to performance data of predicate femoral hip stems.

Technological Characteristics

Short, tapered femoral stem designed for uncemented fixation. Materials and manufacturing processes are consistent with predicate devices. The device is a component of a modular hip prosthesis system.

Indications for Use

Indicated for patients requiring total hip replacement due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, or proximal femur fractures/non-union unmanageable by other techniques. Intended for uncemented use in skeletally mature individuals.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• TaperLoc® Porous and Reduced Distal Femoral Stems – Biomet (K921301)
• TaperLoc® Porous and Hip Prosthesis - Zimmer Inc. (K943230)

Reference Devices

• Constrained Liners (K030047)
• OSS / Salvage Systems / Total Femur (K974558)
• OSS / Salvage Systems / Total Femur (K002757)
• OSS / Salvage Systems / Total Femur (K021380)
• OSS / Salvage Systems / Total Femur (K033871)
• Interlocking Stems (K990830)
• Interlocking Stems (K042774)

Submission Summary (Full Text)

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# JUN 2 9 2005

#### 510(k) Summary

| Applicant/Sponsor: | Biomet Manufacturing Corp.<br>56 East Bell Drive<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587 |
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Kacy Arnold, RN, MBA Contact Person: Requlatory Specialist

Taper 2™ Porous Femoral Stem Proprietary Name:

Femoral Hip Stem Common Name:

Classification Name: The Taper 2™ Porous Femoral Stems included in this submission have the following classification:

- 1. Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis (21 CFR §888.3358), Product Code: LPH
- (21 Cl R good:3550); Frouder South and Course Coated uncemented prosthesis (21 CFR §888.3358), Product Code: MBL

The mating components (modular heads and acetabular shells/liners) for use with the Taper 2™ Porous Femoral Stems have the following classifications:

- 1. Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR §888.3310), Product Code: KWZ
- (21 CFR §888.3320), Product Code: JDL
- (21 CTK 9000.5520), Fryades SS3207, 119888888888.
3. Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis (21 CFR §888.3330), Product Code: KWA
- 4. Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR§ 888.3350), Product Code: JDI
- (21 Cl Rg 000.5550); Trought semi-constrained cemented or nonporous uncemented prosthesis (21 CFR §888.3353), Product Code: LZO
- 6. Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR §888.3353), Product Code, MEH
- C.F.R. §888.3358), Product Code: LPH
- C.T. .N. good.JJJ0), Louder sease ar ...
Hip joint metal/polymer/metal semi-constrained, porous-coated, uncemented prosthesis (21 C.F.R. §888.3358), Product Code: MBL
- 9. Hip joint (hemi-hip) acetabular metal cemented prosthesis, (21 CFR §888.3370), Product Code: KWB

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K05C441 (pg 2 of 2)

- 10. Hip joint (hemi-hip) acetabular metal cemented prosthesis (21 CFR §888.3370), Product Code: LZY
- (21 CFR good.5570), frought beauty of the states or uncemented or uncemented prosthesis
- (21 CFR§888.3390), Product Code: KWY

# Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

TaperLoc® Porous and Reduced Distal Femoral Stems – Biomet (K921301) TaperLoc' Torous and 'Alp Prosthesis - Zimmer Inc. (K943230)

Device Description: The Taper 2™ Porous Femoral Stem is a short, tapered stem, designed to provide Device Description: The Tapel 2 - Porous Femoral Seem of Children Station of Services of Services of Services

Indications for Use: Taper 2™ Porous Femoral Stems

- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 1.
- Rheumatoid arthritis 2.
- Correction of functional deformity 3.
- Correction of functional deformisy
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal 4. freathern of non-unfony ront, unmanageable using other techniques.
- Revision of previously failed femoral head resurfacing component. 51

The Taper 2™ Porous Femoral Stems are intended for non-cemented use only.

Summary of Technologies: The Taper 2™ Porous Femoral Stems are maderials and Summary of Technologies. The Tapel 2 - 1 orous Centralia Center of Children devices. Testing utlize the same manufacturing, packaging and the predicate stems.

Non-Clinical Testing: Reference literature and performance data demonstrate that the Taper 2™ Porous Non-Clinical Testing. " Reference working the predicate femoral hip stems.

All trademarks are property of Biomet, Inc.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

JUN 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tracy Bickel Johnson, RAC Manager of Regulatory Affairs Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K050441

Trade/Device Name: Taper 2TM Porous Femoral Stem Trade/Device Namber: 21 CFR 888.3358, 888.3320, 888.3320, 888.3330, 888.3350, 888.3353.888.3370, 888.3390 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated, ring Joint mottarpoorstis; Hip joint metal/polymer constrained cemented ancemented prosthesis; Hip joint metal/metal semi constrained, with a cemented acetabular component, prosthesis; Hip joint metal/metal semiconstrained, with an uncemented acetabular component; Hip joint metal/ polymer semi-constrained cemented prosthesis; Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis; Hip joint (hemi-hip) acetabular metal cemented prosthesis; Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. Regulatory Class: III Regulatory Class: 111
Product Code: LPH, MBL, KWZ, JDL, KWA, JDI, LZO, MEH, KWB, LZY, KWY

Dated: May 26, 2005 Received: May 27, 2005

Dear Ms. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosary to regists of the Medical Device Amendments, or to connine.co. proc to May 20, 1978, are eccordance with the provisions of the Federal Food, Drug. de rices that have been recuire in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mains of the Act include requirements for annual registration, listing of general controls providing practice, labeling, and prohibitions against misbranding and adulteration.

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## Page 2 - Ms. Tracy Bickel Johnson, RAC

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA may be subject to such additional controller Extrong components of the 200 to 898. In addition, FDA may be found in the Code of Poderal Regaring your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issuation of a bulsvice complies with other requirements of the Act that FDA has made a decommation administered by other Federal agencies. You must of any Federal statutes and regulations and admitted to: registration and listing (21 comply with an the Act 3 requirements, news 801); good manufacturing practice requirements as set and CFK Fart 807), adoling (21 CFR Part 820), and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product Tadiation control provisions (Detice on the vice as described in your Section 510(k) I mis letter will anow you to begin manenes , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , premarket notification. THC 12/1 miding of bassification 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), please If you desire specific advice ion your as [phone]. Also, please note the regulation entitled, Colliact the Office of Compunance in (21CFR Part 807.97). You may obtain Misolanding by release to premainters in the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Stupt Rlurcher

Miriam C. Provost, Ph.D. Acting 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:

Taper 2™ Porous Femoral Stem

#### Indications For Use:

The Taper 2™ Porous Femoral Stem is indicated for use in patients requiring total hip replacement due to the following:

- ving:
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- · Correction of functional deformity
- · Correction of functional delomity
· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur Treatment or non anion, remoration, remorageable by other techniques
- . with head involvement, unmanageable a) one in the may component

Taper 2™ Porous Femoral Stems are intended for uncemented use only.

Specific indications for compatible components that can be used with the above femoral stems include:

### Constrained Liners (K030047)

. ←

Constrained liners are intended for general use in skeletally mature individuals undergoing primary and/or Constrained liners are intended for general use in skilocation, point or bone loss, soft
revision surgery at high risk of hip dislocation due to hislocation, joint or popilon revision surgery at high histocation duct of instoly of prefer and reason of or whom all other options to
[tissue] laxity, neuromuscular disease, or intra-operative instabili [tissue] laxity, nedromasomaline and been considered.

# OSS / Salvage Systems / Total Femur (K974558, K002757, K021380, K033871)

Salvage/Oncology Hip and Total Femur components are also indicated for cases of ligament deficiency, and Salvage/Oncology Hip and Total Femal components and the Components.
The forma and revision of unsuccessful osteotomy or arthrodesis.

#### Interlocking Stems (K990830, K042774)

Interlocking hip stems are indicated for non-cemented application in cases of revision, tracture, Interlocking hip stems are indicated for norrecented application in above for any compromise the fixation and stability oneology of the replacement prosthesis.

Prescription Use ___X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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510(k) Number_________________________________________________________________________________________________________________________________________________________________