G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene

K190660 · Zimmer, Inc. · LPH · Dec 5, 2019 · Orthopedic

Device Facts

• Record ID: K190660
• Device Name: G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene
• Applicant: Zimmer, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Dec 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. Rheumatoid arthritis. Correction of functional deformity. Treatment of non-union. femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement. unmanageable by other techniques. Revision procedures where other treatment or devices have failed. Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented use.

Device Story

The G7 Acetabular System is a modular hip prosthesis used by orthopedic surgeons in clinical settings to replace damaged hip joints. The system consists of titanium alloy acetabular shells (coated with Porous Plasma Spray or additive-manufactured OsseoTi) and modular UHMWPE liners (highly crosslinked or Vitamin-E highly crosslinked). Surgeons select components based on patient anatomy and pathology. The device provides a stable, semi-constrained interface for hip joint reconstruction. By replacing the diseased joint surface, the system restores joint function, corrects deformities, and alleviates pain associated with degenerative conditions or fractures. It is intended for both primary and revision arthroplasty procedures.

Clinical Evidence

No clinical data was deemed necessary. Substantial equivalence is supported by non-clinical bench testing, including push-out, lever-out, torque-out, dynamic impaction, anatomic and distracted head fatigue testing, range of motion evaluation, and rim impingement testing. Additional justifications provided for wear, MRI compatibility, packaging, sterilization, shelf life, and dimensional stability.

Technological Characteristics

Modular hip prosthesis. Shells: Titanium alloy (ASTM F136), Porous Plasma Spray (ASTM F1580), or additive-manufactured OsseoTi (ASTM F2924). Liners: UHMWPE, including highly crosslinked (HXPE) and Vitamin-E highly crosslinked (VEHXPE). Designs include solid, limited hole, multi-hole, and PPS Finned shells; liners available in Neutral, High Wall, Neutral +5mm, or 10-degree face-changing configurations. Semi-constrained design.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, non-union, femoral neck/trochanteric fractures, or revision needs. Suitable for uncemented biological fixation or cemented use depending on component type.

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

• G7 Acetabular System (K142882)
• Continuum® /Trilogy® (K120370)
• IT Acetabular System (K151448)
• Trilogy Acetabular System (K990135)
• Allofit Acetabular System (K003758)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Zimmer, Inc. Josh Davis Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46581-0708 December 5, 2019

Re: K190660

Trade/Device Name: G7 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, LZO, OQG, JDI, OQH, OQI Dated: December 5, 2019 Received: November 5, 2019

Dear Josh Davis:

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.

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

FOR Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices 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)

#### K190660

Device Name G7 Acetabular System Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

Indications for Use (Describe)

· Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.

· Rheumatoid arthritis.

· Correction of functional deformity.

· Treatment of non-union. femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement. unmanageable by other techniques.

· Revision procedures where other treatment or devices have failed.

Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented use.

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)

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# 510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the G7® Acetabular System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

| Sponsor: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708<br>Establishment Registration Number: 1822565 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joshua Davis<br>Specialist, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | 12-March-2019 |
| Subject Device: | Trade Name: G7® Acetabular System<br>Common Name: Hip Prosthesis |
| | Classification Name: |
| | <ul><li>LPH— Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (21 CFR 888.3358)</li><li>LZO—Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented (21 CFR 888.3353)</li><li>OQG—Prosthesis, hip, semi-constrained, metal/polymer + additive, porous uncemented (21 CFR 888.3358)</li><li>JDI— Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (21 CFR 888.3350)</li><li>OQH—Hip, semi-constrained, cemented, metal/polymer + additive, cemented (21 CFR 888.3350)</li><li>OQI—Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented (21CFR 888.3353)</li></ul> |

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## Primary Predicate Device(s):

| | K142882 G7 Acetabular System | Biomet Inc. |
|--|------------------------------|-------------|
|--|------------------------------|-------------|

## Alternate Predicate(s):

| K120370 | Continuum® /Trilogy® | Zimmer Inc. |
|---------|------------------------------|-------------|
| K151448 | IT Acetabular System | Zimmer Inc. |
| K990135 | Trilogy Acetabular<br>System | Zimmer Inc. |
| K003758 | Allofit Acetabular<br>System | Zimmer Inc. |

### Purpose and Device Description:

Intended Use and

The purpose of this subject 510(k) is to introduce a new set of acetabular liners within the G7 Acetabular System. There are no changes to the other components within the system.

The G7 Acetabular System is a modular system, designed to provide numerous options for surgeons and patients in one compatible system. It is modular in design including multiple variants of acetabular shells: a titanium alloy (ASTM F136) shell with an apical hole and plug, the outer surface of the shell is coated with Biomet's Porous Plasma Spray (PPS®) (ASTM F1580) or produced by additive manufacturing using titanium alloy powder as OsseoTi® (ASTM F2924), available in solid shell, limited hole, and multi-hole designs as well as PPS Finned limited hole shells. The other main component is an acetabular liner manufactured from UHMWPE polyethylene, offered in both highly crosslinked polyethylene (HXPE) and Vitamin-E Highly Crosslinked polyethylene (VEHXPE), available in Neutral, High Wall, Neutral +5mm, or 10 Degree Face Changing designs.

- Indications for Use:
- 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis. 2.
- 3. Correction of functional deformity.
- 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.

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- 5. Revision procedures where other treatment or devices have failed.
Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented or uncemented use.

The rationale for substantial equivalence is based on consideration of the following characteristics:

- Intended Use: Same as the predicates ●
- Indications for Use: Same as the G7 Acetabular . System predicate, similar to the Continuum/Trilogy IT predicate
- o Materials: Same polyethylene material as the Continuum/Trilogy IT predicate
- Design Features: Similar to the G7 Acetabular o System predicate, similar to the Continuum/Trilogy IT predicate
- Sterilization: Same as the Continuum/Trilogy IT ● predicate

Summary of Performance Data (Nonclinical and/or Clinical)

Summary of Technological

Characteristics:

- Non-Clinical Tests: Mechanical testing and ● engineering analysis was conducted to demonstrate that the modifications did not adversely affect safety and efficacy, and to demonstrate substantial equivalence to the predicate components. The test reports are listed below:
- Push Out Testing o
- o Lever Out Testing
- Torque Out Testing O
- Dynamic (Impaction) Insertion Testing O
- Anatomic Fatigue Testing O
- Distracted Head Fatigue Testing O
- Range of Motion Evaluation O
- Laser Etch Verification O
- O Wear Justification
- MRI compatibility O
- Packaging Adoption O
- Sterilization Adoption O
- Shelf Life Justification O
- 0 Dimensional Stability Justification

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- o Rim Impingement Testing
- Clinical Tests: 0
- o Clinical data was not deemed necessary for the subject device.

## Substantial Equivalence Conclusion

The subject device has the same intended use and indications for use as the G7 Acetabular System predicate device. The subject device has similar technological characteristics to the predicates, and the performance data and analyses demonstrate that:

- any differences do not raise new questions of safety ● and effectiveness; and
- o the proposed device is at least as safe and effective as the legally marketed predicate devices.