UNISYN PLUS HIP STEM

K120595 · Consensus Orthopedics, Inc. · LWJ · Oct 12, 2012 · Orthopedic

Device Facts

• Record ID: K120595
• Device Name: UNISYN PLUS HIP STEM
• Applicant: Consensus Orthopedics, Inc.
• Product Code: LWJ · Orthopedic
• Decision Date: Oct 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. A. Proximal femoral fractures. B. Avascular necrosis of the femoral head. C. Non-union of proximal femoral neck fractures. D. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities. UNISYN assemblies with roughened and plasma coated bodies are intended for cemented or uncemented use. UNISYN assemblies with plasma/HA or HA coated bodies are intended for uncemented use only.

Device Story

Modular hip prosthesis system consisting of neck, body, and stem components. Subject device introduces modified 'Plus' stems with adjusted body thickness to improve contact with medullary canal during revision surgery. Stems available in neutral or +1 mm styles, 10-20 mm diameters, and 110-210 mm lengths. Used by orthopedic surgeons in clinical/surgical settings for hip arthroplasty. Implanted to restore joint function and stability in patients with degenerative or traumatic hip conditions. Design modifications maintain compatibility with existing UniSyn system components and surgical techniques.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, specifically distal fatigue performance evaluation per ISO 7206-4 on a worst-case stem configuration.

Technological Characteristics

Modular hip prosthesis system. Materials and design construct are identical to predicate components. Features include grit-blasted, plasma-coated, or HA-coated bodies. Stems available in neutral or +1 mm styles, 10-20 mm diameters, and 110-210 mm lengths. Distal fatigue performance tested per ISO 7206-4. No changes to sterilization or manufacturing processes.

Indications for Use

Indicated for patients with significantly impaired joints due to rheumatoid, osteoarthritis, or post-traumatic arthritis; revision of failed hip procedures; proximal femoral fractures; avascular necrosis; non-union of femoral neck fractures; or structural/developmental hip conditions (e.g., dysplasia, coxa vara/valga).

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• Triton Hip System (K003649)
• UniSyn HA Plasma Modular Hip (K062383)

Submission Summary (Full Text)

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## k 120 595

#### 2. 510(k) SUMMARY

OCT 1 2 2012

| Sponsor Name: | Consensus Orthopedics, Inc.<br>1115 Windfield Way, Suite 100<br>El Dorado Hills, CA 95762 | | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------|--|--|
| 510(k) Contact: | Matthew M. Hull, RAC<br>Phone: [phone]<br>e-mail: [e-mail] | | |
| Date Prepared: | 11 October 2012 | | |
| Trade Name: | UNISYN Plus stem | | |
| Common Name: | Stem, modular hip prosthesis. | | |
| Device Class: | 2 | | |
| Classification Name: | Prosthesis, Hip, Semi-Constrained, Metal/Polymer,<br>Uncemented (21 CFR 888.3360, LWJ) | | |
| | Prosthesis, Hip, Semi-Constrained, Metal/Polymer,<br>Cemented (21 CFR 888.3350, JDI) | | |
| | Prosthesis, Hip, Semi-Constrained,<br>Metal/Ceramic/Polymer, Cemented or Non-Porous,<br>Uncemented (21 CFR 888.3353, LZO) | | |

#### Device Description:

The UniSyn Hip System was originally cleared as a modular hip system for Hayes Medical under the name "Triton", modifications to the system were cleared in a subsequent submission by Hayes under the UniSyn name. Hayes Medical changed its name to Consensus Orthopedics in 2008. This system consists of three primary components: the neck, the body, and the stem. This submission is to addition of a set of modified ("Plus") stems.

These minor modifications in body thickness are designed to allow for better contact between the implant and the inner surface of the medullary canal during revision surgery. The sizes of stems offered with the modified design are within the ranges previously cleared for the UniSyn system. The Plus stems are offered in neutral or +1 mm styles, short or long, in 10 to 20 mm diameters, and lengths from 110 to 210 mm. There is no change to the manufacturing, packaging, or sterilization processes. This change will not affect the indications for use nor any of the labeling.

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# 120595

#### Indications for Use:

A) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic arthritis.

B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.

C) Proximal femoral fractures.

D) Avascular necrosis of the femoral head.

E) Non-union of proximal femoral neck fractures.

F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.

UNISYN stems used with roughened and plasma coated bodies are intended for cemented or uncemented use. UNISYN stems used with plasma/HA or HA coated bodies are intended for uncemented use only.

### Substantial Equivalence:

### Technological Characteristics/Substantial Equivalence:

The new "Plus" stems for the UniSyn hip systems employ the same materials, basic design features, manufacturing processes, packaging, and indications as the predicate stems for the UHS. Therefore, the new Plus stems for use with the UNISYN Hip System are substantially equivalent to legally marketed predicate devices (Table 2.1).

| 510(k)<br>Number | Trade Name | 510(k) holder | 510(k)<br>Release Date |
|------------------|------------------------------|---------------------|------------------------|
| K003649 | Triton Hip System | Hayes Medical, Inc. | 02/23/2001 |
| K062383 | UniSyn HA Plasma Modular Hip | Hayes Medical, Inc. | 12/21/2006 |

Table 2.1: Legally marketed devices to which substantial equivalence is claimed:

#### Non-Clinical Performance Data:

The UNISYN Hip System (UHS) implant components use the identical materials, design construct features of the predicate components. The UHS implant components were evaluated using a Failure Modes and Effects Analysis (FMEA). Distal fatigue performance of the UniSyn Plus grit blasted stem was evaluated per ISO 7206-4 on a worst case example. No other nonclinical bench testing was deemed necessary over that used in support of the predicates based on identical design and materials.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

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

OCT 12 2012

Consensus Orthopedics, Incorporated % Mr. Matthew M. Hull, RAC Director, QS and RA 1115 Windfield Way, Suite 100 El Dorado Hills, California 95762

Re: K120595

Trade/Device Name: UNISYN Hip System Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: LWJ, JDI, LZO Dated: October 4, 2012 Received: October 5, 2012

Dear Mr. Hull:

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. Matthew M. Hull, RAC

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

For
J. Melkerson

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

Enclosure

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## 12-0595

#### 1. INDICATIONS FOR USE STATEMENT

510(k) Number: K120595

Device Name: UNISYN Hip System

#### Indications for Use:

Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.

- A. Proximal femoral fractures.
- B. Avascular necrosis of the femoral head.
- C. Non-union of proximal femoral neck fractures.
- D. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.

UNIS YNTM assemblies with roughened and plasma coated bodies are intended for cemented or uncemented use. UNISYNTM assemblies with plasma/HA or HA coated bodies are intended for uncemented use only.

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

Over the Counter Use · (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

K. Harrel.

Post

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120595