ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS

K051335 · Exactech, Inc. · JDI · Jun 21, 2005 · Orthopedic

Device Facts

• Record ID: K051335
• Device Name: ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS
• Applicant: Exactech, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Jun 21, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. AcuMatch® P-Series and AcuMatch® L-Series press-fit femoral stems are intended for press-fit fixation. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.

Device Story

AcuMatch 12/14 Press-Fit Femoral Stems are orthopedic implants used in hip replacement surgery. The device consists of a titanium alloy femoral stem with a trapezoidal cross-section and distal taper. The P-Series features a plasma-spray surface enhancement, while the L-Series has a corundum finish; both offer an optional hydroxyapatite (HA) coating. The stems are designed for press-fit fixation, though non-HA coated versions may be used with bone cement at the surgeon's discretion. The device is implanted by an orthopedic surgeon in a clinical/hospital setting. It serves as a structural replacement for the femoral head and neck, restoring joint function and mobility for patients suffering from degenerative hip disease or fractures. Modifications from the predicate include a threaded insertion hole (P-Series), expanded taper threadform tolerances, and a collared P-Series option.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and engineering analyses.

Technological Characteristics

Materials: Titanium alloy (ASTM F1472). Design: Trapezoidal cross-section, distal taper. Surface: Plasma-spray (P-Series) or corundum finish (L-Series), with optional hydroxyapatite (HA) coating. Fixation: Press-fit or cemented (non-HA versions).

Indications for Use

Indicated for skeletally mature individuals undergoing primary hip replacement for osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative hip conditions, or proximal femoral fractures. Also indicated for ankylosing spondylitis, congenital hip dysplasia, and revision of failed reconstructions with sufficient bone stock, or to restore mobility after previous fusion.

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

• AcuMatch 12/14 P-Series Plasma Press-Fit Femoral Stems (K041906)
• AcuMatch 12/14 L-Series Press-Fit Femoral Stems (K041906)

Submission Summary (Full Text)

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**Exactech**

JUN 2 1 2005

FL 32653

FAX [phone]

# Exactech® AcuMatch 12/14 Press-Fit Femoral Stems

#### 510(k) Summary of Safety and Effectiveness Special 510(k)

#### Trade or proprietary or model name(s):

AcuMatch 12/14 P-Series Press-Fit Plasma Femoral Stems AcuMatch 12/14 L-Series Press-Fit Femoral Stems

# Information on devices to which substantial equivalence is claimed:

| 510(k) | Trade or Proprietary or Model Name | Manufacturer |
|-------------------|-----------------------------------------------------------------------------------------------------------|---------------|
| Number<br>K041906 | AcuMatch 12/14 P-Series Plasma Press-Fit Femoral Stems<br>AcuMatch 12/14 L-Series Press-Fit Femoral Stems | Exactech, Inc |

#### INDICATIONS

All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

AcuMatch® P-Series and AcuMatch® L-Series press-fit femoral stems are intended for press-fit fixation.

Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.

#### Special 510(k) Modifications

The AcuMatch 12/14 Press-Fit femoral stems were modified from the predicate as follows:

- The geometry of the insertion hole feature was modified from an oblong slot to an . oblong slot with threads (P-Series only).
- The tolerance of the 12/14 taper threadform geometry was expanded. .
- Collared 12/14 P-Series Press-Fit Stem option was added. .

Rev. 05/19/05

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Exactech

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FAX [phone]

## Exactech® AcuMatch 12/14 Press-Fit Femoral Stems

#### 510(k) Summary of Safety and Effectiveness Special 510(k)

## AcuMatch 12/14 Press-Fit Femoral Stems

AcuMatch 12/14 Press-Fit femoral stems are composed of titanium alloy (ASTM F1472), have a trapezoidal cross-sectional geometry and distal taper.

- 12/14 P-Series model has a plasma-spray surface enhancement. ●
- 12/14 L-Series model has a corundum finish. .

Both models have a hydroxyapatite (HA) coating option. The femoral stems are intended Doth models have a try are models without the HA coating may be used with bone cement at the discretion of the surgeon.

#### Conclusion:

Conclusion." results one clightering - 12:14 Press-Fit Femoral Stem components would be adequate for anticipated in vivo use. This includes empirical testing and engineering analyses. Based on successful results we conclude that the proposed devices are substantially equivalent to Exactech's predicate femoral stems.

Rev. 05/19/05

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JUN 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Maritza Elias Regulatory Representative Exactech, Inc. 2320 N.W. 66th Court Gainesville, Florida 32653

Re: K051335

Trade/Device Name: Exactech Acumatch 12/14 Press-Fit Femoral Stems Regulation Number: 21 CFR 888.3353, 888.3350 Regulation Name: Hip joint metal/cemented/polymer semi-constrained cemented or nonregaration Names - Hip joint metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JDI, LWJ, MEH, LZO Dated: May 17, 2005 Received: May 23, 2005

Dear Ms. Elias:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for doo based or 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou mayy atch s 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 (PMA), it rr your de rise to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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## Page 2 – Ms. Maritza Elias

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (seting your device as described in your Section 510(k) This letter will anow you to oegin mains of substantial equivalence of your device to a legally premarket notheadon. The PDF mining sitems of 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 acriously at [phone]. Also, please note the regulation entitled, Comaci the Office of Comphanes and in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnation en Journer 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,

Miriam C. Provost

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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# Exactech®, Inc.

# Exactech AcuMatch 12/14 Press-Fit Femoral Stems

## Indications for Use

K051335 510(k) Number:

#### INDICATIONS

INDICATIONS
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the surgeon as the preferred treatment. Components hip dysplassia, revision of the surgeon as the preletted treatinent. Configure on tall hip dysplass, revision of
potentially indicated for ankylosing spondylitis, congent, and to restore potentially indicated for allRylosing spondyinia, occaged is present, and to restore mobility resulting from previous fusion.

AcuMatch® P-Series and AcuMatch® L-Series press-fit femoral stems are intended for press-fit fixation.

Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.

Prescription Use

X

Over the Counter Use _

Please do not write below this line - use another page if needed.

or

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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05/18/05