ALPINE HIP STEM; ALPINE HA HIP STEM

K141001 · Ortho Development · LPH · Jul 30, 2014 · Orthopedic

Device Facts

• Record ID: K141001
• Device Name: ALPINE HIP STEM; ALPINE HA HIP STEM
• Applicant: Ortho Development
• Product Code: LPH · Orthopedic
• Decision Date: Jul 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Alpine Hip Stem is intended for use in total hip replacement surgery or hemi-arthroplasty. Hip arthroplasty is intended to provide increased patient mobility and decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants.

Device Story

Single-piece, conical tapered femoral hip prosthesis; designed for cementless, press-fit fixation in medullary canal. Features 12/14 trunnion for modular femoral head attachment. Used in total hip arthroplasty or hemi-arthroplasty to replace damaged hip joints, increase patient mobility, and decrease pain. Operated by orthopedic surgeons in clinical/hospital settings. Provides structural replacement for femoral component of hip joint; relies on press-fit mechanical stability to support patient weight and restore joint function.

Clinical Evidence

Bench testing only. No clinical studies performed. Testing included mechanical performance per ISO 7206-6:2013, distal fatigue per ISO 7206-4:2010, range of motion analysis per ISO 21535:2007, and microstructure/mechanical property analysis of plasma spray coating.

Technological Characteristics

Single-piece, conical tapered femoral stem. Material: Titanium alloy (ASTM F136, Ti-6Al-4V ELI). Proximal surface: Plasma sprayed titanium alloy (ASTM F1580). Fixation: Uncemented press-fit. Modular interface: 12/14 trunnion. Geometry: Conical tapered distal stem with circular cross-section.

Indications for Use

Indicated for total hip arthroplasty or hemi-arthroplasty in patients with notably impaired hip joints due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, failed prior hip surgery, proximal femoral neck fractures/dislocation, idiopathic avascular necrosis, non-union of proximal femoral neck fractures, unmanageable fractures, benign/malignant bone tumors, or congenital dysplasia/structural abnormalities with sufficient bone stock for prosthesis seating. For uncemented, press-fit use only.

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

• Ovation™ Hip Stem (K062775)
• Global Taper Tapered Hip System (K963509)
• Novation 12/14 Press-Fit Femoral Stem (K042842)

Submission Summary (Full Text)

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## JUL 3 0 2014

## Section 5 510(k) Summary

| Name of Sponsor: | Ortho Development Corporation<br>12187 South Business Park Drive<br>Draper, Utah 84020 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Mike Ensign<br>Director of Regulatory Affairs and Quality Assurance<br>Telephone: [phone]<br>Facsimile: [phone]<br>Email: [e-mail] |
| Date Prepared: | July 18, 2014 |
| Proprietary Name: | Alpine Hip Stem |
| Common Name: | Hip Stem Prosthesis |
| Classification: | 21 CFR 888.3358, Hip joint metal/polymer/metal semi-constrained<br>porous-coated uncemented prosthesis<br>21 CFR 888.3353, Hip joint metal/ceramic/polymer semi-<br>constrained cemented or nonporous uncemented prosthesis<br>Class II device |
| Device Product Code: | LPH, LZO, KWY, KWL, MBL |
| Predicate Devices: | Ovation™ Hip Stem (K062775) Ortho Development<br>Global Taper Tapered Hip System (K963509) Smith & Nephew<br>Novation 12/14 Press-Fit Femoral Stem (K042842) Exactech |

#### Device Description

The Alpine Hip Stem is a single-piece, conical tapered femoral hip prostheses, designed for single, cementless use. The stem has a neck with a 12/14 trunnion for modular attachment to femoral heads.

The Alpine Hip Stem is manufactured from titanium alloy (per ASTM F136, Ti-6Al-4V ELI) and device fixation is achieved via press-fit in the medullary canal, which maximizes contact between the stem and bone. The proximal portion is plasma sprayed with titanium alloy (per ASTM F1580).

#### Intended Use

The Alpine Hip Stem is intended for use in total hip replacement surgery or hemi-arthroplasty. Hip arthroplasty is intended to provide increased patient mobility and decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants.

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#### Indications for Use

This device is intended for use in total hip arthroplasty or hemi-arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

- Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis, and/or post traumatic 1. arthritis
- 2. Previously failed hip surgery
- 3. Proximal femoral neck fractures or dislocation
- 4. Idiopathic avascular necrosis of femoral head
- Non-union of proximal femoral neck fractures 5.
- 6. Treatment of fractures that are unmanageable using other forms of therapy
- Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where 7. sufficient bone stock exists to properly seat the prosthesis

#### Summary of Technological Characteristics

The Alpine Hip Stem has the same technological characteristics as the predicate devices. The subject device stem is a single-piece, conical tapered uncemented hip stem. The stem has proximal stem geometry to aid in the fill and locking in the medullary canal. The conical tapered distal stem has a circular cross-section for fit in the medullary canal. Compared to the predicate devices, the Alpine Hip Stem has the same intended use, basic design, and materials.

#### Basis of Substantial Equivalence

The Alpine Hip Stem is substantially equivalent to the previously cleared predicate devices based on similarities in intended use, overall design, materials, manufacturing methods, packaging, mechanical performance and sterilization.

#### Test Summary

Non-clinical performance testing has been conducted in accordance with ISO 7206-6:2013 and distal fatigue in accordance with ISO 7206-4:2010. Range of motion analysis was performed per ISO 21535:2007. The plasma spray coating underwent testing for mechanical properties and microstructure analysis. No clinical studies were performed.

#### Conclusions

Based on the similarities to the predicate devices, and a review of the Alpine Hip Stem is substantially equivalent to the predicate devices that were cleared under K062775 and K963509.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 30, 2014

Ortho Development Corporation Mr. Mike Ensign Director of Regulatory Affairs and Quality Assurance 12187 South Business Park Drive Draper, Utah 84020

Re: K141001 Trade/Device Name: Alpine Hip Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH. LZO, MBL, KWY, KWL Dated: July 10, 2014 Received: July 11, 2014

Dear Mr. Ensign:

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 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) 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Mike Ensign

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours, Lori A. Wiggins

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K141001

Device Name Alpine Hip Stem

Indications for Use (Describe)

This device is intended for use in total hip arthroplasty or hemi-arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joint due to osteoathritis, rheumatoid arthritis, and/or post traumatic arthritis

2. Previously failed hip surgery

3. Proximal femoral neck fractures or dislocation

4. Idiopathic avascular necrosis of femoral head

5. Non-union of proximal femoral neck fractures

6. Treatment of fractures that are unmanageable using other forms of therapy

7. Benign or malignant bone tumors, congenital dysplasia or other structural abormalities where sufficient bone stock exists to properly seat the prosthesis

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

:

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Elizabeth₪»Erank -S

Division of Orthopedic Devices

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