X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER

K130365 · Encore Medical L.P. · OQG · Sep 23, 2013 · Orthopedic

Device Facts

• Record ID: K130365
• Device Name: X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER
• Applicant: Encore Medical L.P.
• Product Code: OQG · Orthopedic
• Decision Date: Sep 23, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Joint replacement is indicated for patients suffering from disability due to: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; rheumatoid arthritis; correction of functional deformity; femoral fracture. This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended for cementless use only

Device Story

Acetabular liner component for hip replacement surgery; manufactured from highly cross-linked polyethylene infused with pharmaceutical-grade alpha-tocopherol (Vitamin E). Device serves as bearing surface in hip arthroplasty; implanted by orthopedic surgeons in clinical settings. Vitamin E infusion intended to improve oxidative stability and wear resistance of polyethylene. Device dimensions and configurations (neutral, 10°, 20° hooded) match existing cleared liners. Provides mechanical articulation surface for femoral head; facilitates joint function restoration in patients with degenerative or traumatic hip conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including mechanical characterization, push-out, lever-out, torsion, rim impingement, fatigue crack propagation, Izod impact, small punch, tensile, FTIR, wear analysis, wear particle analysis, extraction testing, animal toxicological response, and cytotoxicity testing.

Technological Characteristics

Highly cross-linked polyethylene infused with alpha-tocopherol (Vitamin E). Available in 28mm, 32mm, 36mm, 40mm, and 44mm ID sizes with neutral, 10°, and 20° hooded configurations. Designed for cementless use. Sterilization method not specified.

Indications for Use

Indicated for patients with disability due to noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, or femoral fracture, including salvage of failed surgical attempts. Intended for cementless 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

• DJO Surgical X-alt™ Highly Cross Linked Acetabular Liner (K072154)
• DJO Surgical 3DKnee Tibial Insert with Vitamin E (K091956)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) Summary

Date: February 11, 2013

Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758

Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: [phone] Fax: [phone] Email: [e-mail]

| Product | Classification | Product Code |
|----------------------------------------------------------------|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| X-altTM Highly Cross Linked Acetabular<br>Liner with Vitamin E | Class II | LPH - Hip joint metal/polymer/metal semi-constrained<br>porous-coated uncemented prosthesis per 21 CFR 888.3358<br>OQG - Hip prosthesis, semi-constrained, cemented.<br>metal/polymer, + additive, porous, uncemented per 21 CFR<br>888.3358 |

Description: A highly cross linked polyethylene acetabular liner infused with pure liquid phamnaceutical grade alpha-tocopheral. The liners are the same dimensions and size offerings as the currently cleared Highly Cross Linked Poly liners (K072154) (28mm, 32mm, 36mm, 40mm, and 44mm 1D, with neutral, 10° and 20° hooded configurations available in each ID).

#### Indications for Use:

Joint replacement is indicated for patients suffering from disability due to:

- noninflanımatory degenerative joint disease including osteoarthritis and avascular necrosis of the . natural femoral head;
- . rheumatoid arthritis;
- correction of functional deformity: ●
- femoral fracture. .

This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended for cementless use only

### Predicate Device:

SEP 2 3 2013

- DJO Surgical X-alt™ Highly Cross Linked Acetabular Liner K072154 .
DJO Surgical 3DKnee Tibial Insert with Vitamin E - K091956 .

Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design features, materials, indications, sterilization, packaging and intended use.

Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected conditions. Testing included mechanical characterization testing, push out, lever out, torsion, rim impingement, fatigue crack propagation, Izod impact, small punch, tensile, FTIR, wear, optical and SEM analysis, wear particle analysis, extraction testing, animal implant for toxilogical response, and cviotoxicity. All testing has determined that the device is substantially equivalent to the predicate devices.

Clinical Testing: None provided.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public I lealth Service

Food and Drug Administration 10903 New Hampshire Asenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

September 23, 2013

Encore Medical, L.P. Ms. Teffant Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758

Re: K130365

Trade/Device Name: X-alt" Highly Cross Linked Acctabular Liner with Vitamin E 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: OQG, LPH Dated: July 15, 2013

Received: July 16, 2013

Dear Ms. Hutto:

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

{2}------------------------------------------------

Page 2 - Ms. Teffany Hutto

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Reportal?roblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Eriñ I. Keith

for

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

Enclosure

{3}------------------------------------------------

510(k) Number (if known):

Device Name: X-alt™ Highly Cross Linked Acetabular Liner with Vitamin E

Indications for Use:

## X-alt™ Highly Cross Linked Acetabular Liner with Vitamia E Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis of the natural femoral head;
- . rheumatoid arthritis;
- correction of functional deformity; .
- femoral fracture. .

This device may also be indicated in the salvage of previously failed surgical attempts.

This device is intended for cementless use only

Over-The-Counter Use Prescription Use _ X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Elizabeth L. Frank -S

Division of Orthopedic Devices

Page I of I