Predicate Devices

K142882, K120370, K151448, K990135, K003758

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a modular hip replacement system and its components, focusing on materials, design options, and mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

Yes
The device is a G7 Acetabular System, which is a hip implant used for conditions like osteoarthritis, rheumatoid arthritis, correction of functional deformity, and treatment of non-union femoral neck fractures, which are all conditions that affect the body and require treatment.

Diagnostic

No

Explanation: The device description and intended use indicate that the G7 Acetabular System is a modular implant designed for joint replacement procedures, not for diagnosing medical conditions. Its purpose is to treat degenerative joint disease and fractures, not to identify or characterize them.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components made of titanium alloy and polyethylene, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a surgical implant for treating various conditions of the hip joint. This is a therapeutic device, not a diagnostic one.
Device Description: The description details the materials and design of an acetabular system (part of a hip replacement). This is consistent with a surgical implant.
Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
Performance Studies: The performance studies focus on mechanical testing and engineering analysis, which are relevant to the safety and efficacy of a surgical implant, not a diagnostic test.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The G7 Acetabular System is indicated for:
· 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.

Product codes (comma separated list FDA assigned to the subject device)

LPH, LZO, OQG, JDI, OQH, OQI

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip joint

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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
Lever Out Testing
Torque Out Testing
Dynamic (Impaction) Insertion Testing
Anatomic Fatigue Testing
Distracted Head Fatigue Testing
Range of Motion Evaluation
Laser Etch Verification
Wear Justification
MRI compatibility
Packaging Adoption
Sterilization Adoption
Shelf Life Justification
Dimensional Stability Justification
Rim Impingement Testing
Clinical Tests: Clinical data was not deemed necessary for the subject device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K142882, K120370, K151448, K990135, K003758

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
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.(b)
Classification. Class II.

Summary

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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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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.
P.O. Box 708
Warsaw, IN 46581-0708
Establishment Registration Number: 1822565 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joshua Davis
Specialist, Regulatory Affairs
Telephone: (508) 294-0749
Fax: (574) 372-4605 |
| Date: | 12-March-2019 |
| Subject Device: | Trade Name: G7® Acetabular System
Common Name: Hip Prosthesis |
| | Classification Name: |
| | LPH— Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (21 CFR 888.3358)LZO—Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented (21 CFR 888.3353)OQG—Prosthesis, hip, semi-constrained, metal/polymer + additive, porous uncemented (21 CFR 888.3358)JDI— Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (21 CFR 888.3350)OQH—Hip, semi-constrained, cemented, metal/polymer + additive, cemented (21 CFR 888.3350)OQI—Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented (21CFR 888.3353) |

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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
System	Zimmer Inc.
K003758	Allofit Acetabular
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.
- 1. Correction of functional deformity.
- 1. 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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1. 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.