DJO Acetabular System

K190057 · Encore Medical L.P. · LPH · Jun 7, 2019 · Orthopedic

Device Facts

• Record ID: K190057
• Device Name: DJO Acetabular System
• Applicant: Encore Medical L.P.
• Product Code: LPH · Orthopedic
• Decision Date: Jun 7, 2019
• 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 indicated for cementless use.

Device Story

DJO Acetabular System is a total hip replacement implant; consists of porous-coated titanium acetabular cups, bone screws, and highly cross-linked polyethylene liners with Vitamin E. Designed for cementless fixation; compatible with existing DJO femoral stems and heads. Used by orthopedic surgeons in clinical settings to replace the acetabulum. Device restores joint function; addresses disability from degenerative disease, arthritis, or fracture. Output is a mechanical prosthetic interface; clinical decision-making relies on surgeon assessment of patient anatomy and pathology. Benefits include improved mobility and pain relief for patients requiring hip arthroplasty.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical mechanical testing, including Range of Motion analysis, impingement testing, and strength testing (push out, lever out, torsional). Endotoxin levels verified via Kinetic Chromogenic method.

Technological Characteristics

Materials: Porous-coated titanium (cups), highly cross-linked polyethylene with Vitamin E (liners). Design: Cementless, semi-constrained, porous-coated uncemented prosthesis. Components: Acetabular cups, bone screws, liners. Sterilization: Not specified. Connectivity: None (mechanical implant).

Indications for Use

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

• FMP Hemispherical Acetabular Shells (K072888)
• FMP HXe+ Acetabular Liner (K130365)
• FMP HXe+ Extended Acetabular Liner (K172651)
• Cancellous Bone Screws (K931665)
• G7 Acetabular System (K121874)
• Trident Acetabular System (K040412)

Submission Summary (Full Text)

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June 07, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Encore Medical, L.P. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Blvd. Austin, Texas 78758

Re: K190057

Trade/Device Name: DJO Acetabular System 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, OQG Dated: January 10, 2019 Received: January 11, 2019

Dear Teffany 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K190057

Device Name DJO Acetabular System

#### Indications for Use (Describe)

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 indicated for cementless use.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

Date: June 7, 2019

Manufacturer: DJO Surgical (Legal Name: 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 | Common Name | Classification | Product Code |
|-----------------------|-------------------|----------------|--------------|
| DJO Acetabular System | Total Hip Implant | Class II | LPH, OQG |

| Product Code | Regulation and Classification Name |
|--------------|------------------------------------------------------------------------------------------------------------------|
| LPH | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis per 21<br>CFR 888.3358 |
| OQG | Hip prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented<br>per 21 CFR 888.3358 |

### Description:

The DJO Acetabular System allows for the total replacement of the acetabulum. The system consists of porous coated titanium acetabular cups, bone screws for use with the cups, and acetabular liners manufactured from highly crossed linked polyethylene with Vitamin E. It is designed for compatibility with currently cleared DJO stems and femoral heads.

### 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 indicated for cementless use.

## Predicate Devices:

| System Name | Manufacturer | 510(k) Clearance |
|-------------------------------------|----------------------|------------------|
| FMP Hemispherical Acetabular Shells | Encore Medical, L.P. | K072888 |
| FMP HXe+ Acetabular Liner | Encore Medical, L.P. | K130365 |
| FMP HXe+ Extended Acetabular Liner | Encore Medical, L.P. | K172651 |
| Cancellous Bone Screws | Encore Medical, L.P. | K931665 |
| G7 Acetabular System | Biomet | K121874 |
| Trident Acetabular System | Stryker | K040412 |

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### Comparable Features to Predicate Device(s):

## K190057 p. 2/2

Acetabular Cup: Materials, size offering, style offering, key material thickness, porous coating, outer diameter, internal surface finish, anti-rotation feature, number of internal scallops, dome thread plug, screw hole options, screw hole layout, packaging, sterilization, manufacturing process.

Acetabular Liner: Material, size offering, number of scallops, minimum wall thickness, wear, impingement, poly locking feature, surface finish, sterilization, packaging, manufacturing process.

Bone Screw: Thread form and diameter, screw lengths, self tapping screw tip, surface finish, drive feature, material, sterilization, packaging, manufacturing process.

Implant Relationship: ROM, jump distance, poly liner locking mechanism, poly liner collar, poly liner articulating surface, bone screw angulation, bone screw drill preparation, titanium dome plug cover

### Key Differences in Subject Device to Predicate:

There are no key differences between the subject device and predicate devices.

Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected conditions. This testing includes:

- Range of Motion Analysis
- Impingement Testing
- Push Out, Lever Out, and Torsional Strength

All testing has determined that the device is substantially equivalent to the predicate devices.

Endotoxin Assessment: DJO Surgical conducts device testing to assure that pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing.

Clinical Testing: Clinical testing was not required

Conclusions: All testing and evaluations demonstrate that the device is substantially equivalent to the predicates identified.