(131 days)
No
The document describes a modular acetabular system and its components, focusing on mechanical properties and indications for use in hip replacement surgery. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes.
The device is a component of a total hip prosthesis used to correct functional deformity, treat degenerative joint disease, and revise failed procedures, which are all therapeutic interventions.
No
Explanation: The provided text describes a medical device, the G7 Acetabular System, which is a modular system for total hip prostheses. Its intended uses and device description focus on treatment and anatomical replacement, not on diagnosing medical conditions.
No
The device description clearly outlines physical components like acetabular shells, femoral stems, liners, and a femoral constrained head, indicating it is a hardware-based medical device.
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 hip joint conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details components of a hip replacement system (acetabular shells, femoral stems, liners, femoral heads). These are physical implants used in surgery.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens (like blood, tissue, or urine) outside of the body to diagnose a condition.
- Performance Studies: The performance studies focus on mechanical testing of the implant components, not on diagnostic accuracy metrics like sensitivity or specificity.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
-
- Non-inflammatory 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.
Additional indications for Biomet G7 Freedom Constrained Liners:
The Biomet G7 Freedom Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
Product codes
LPH, LZO, OQG, KWZ, JDI, OQH, OQI, PBI
Device Description
The G7 Acetabular System is a modular system, designed to provide numerous options for surgeons and patients in one compatible system. Further liner options are being added to the G7 Acetabular System which include: Neutral +5mm liner in ArComXL or E1; G7 Freedom Constrained Liners in two new profiles, the +5mm and the 10 Degree in E1. as well as a line extension to include G7 Freedom Neutral Liners in a size 32mm: and a new Femoral Constrained Head in Size 32mm (Cobalt Chrome, ASTM F1537).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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)
The mechanical tests and engineering analyses demonstrate the G7 Freedom and Offset Liners, Freedom Head, Size 32, are substantially equivalent to the predicate devices. No animal or clinical testing was required to support substantial equivalence. A description of the tests is located below.
- Axial Pull-out Test (Freedom Head)
- Lever-out Test (Freedom Head) .
- o Vertical Load Fatique Test (Poly Liners)
Since the internal design, materials and locking mechanism of the acetabular liners are the same as the G7 liners cleared in K121874, the non-clinical testing submitted for K121874 can be used as justification for the performance of the new G7 liners.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K121874, K030047, K043537, K870271
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2015
Biomet, Incorporated Ms. Becky Earl Senior Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46581
Re: K142882 Trade/Device Name: G7 Freedom and Offset Liners, Freedom Head, Size 32 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, KWZ, JDI, OQI, PBI, OQH Dated: January 6, 2015 Received: January 8, 2015
Dear Ms. Earl:
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
1
Page 2 - Ms. Becky Earl
(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 (OS) 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
G7 Freedom and Offset Liners, Freedom Head, Size 32
Indications for Use (Describe)
-
- Non-inflammatory 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.
Additional indications for Biomet G7 Freedom Constrained Liners:
The Biomet G7 Freedom Constrained Liner is indicated for use as a component of a
total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
| 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 G7 Freedom and Offset Liners, Freedom Head, Size 32 | Traditional 510(k)
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 Freedom and Offset Liners. Freedom Head, Size 32, 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: | Biomet, Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact: | Becky Earl
Senior Regulatory Affairs Specialist |
| Date: | September 30, 2014 |
| Subject Device: | Trade Name: G7 Freedom and Offset Liners, Freedom Head, |
| Size 32 | |
| | Common Name: Offset and constrained acetabular liners, and
femoral head. |
| | 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) |
| | • KWZ—Prosthesis, hip, constrained, cemented or
uncemented, metal/polymer (21 CFR 888.3310) |
| | • 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 (21
CFR 888.3353) |
| | • PBI—Prosthesis, hip, constrained, cemented or
uncemented, metal/polymer + additive (21 CFR 888.3310) |
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Legally marketed devices to which substantial equivalence is claimed:
- K121874, G7 Acetabular System, Biomet, Inc. .
- . K030047, K043537 Ringloc Freedom Constrained Liners, Biomet, Inc.
- K870271 S-ROM Poly Dial Constrained Socket for Acetabular Cup, Joint Medical . Products (now owned by DePuy)
Device Description
The G7 Acetabular System is a modular system, designed to provide numerous options for surgeons and patients in one compatible system. Further liner options are being added to the G7 Acetabular System which include: Neutral +5mm liner in ArComXL or E1; G7 Freedom Constrained Liners in two new profiles, the +5mm and the 10 Degree in E1. as well as a line extension to include G7 Freedom Neutral Liners in a size 32mm: and a new Femoral Constrained Head in Size 32mm (Cobalt Chrome, ASTM F1537).
Intended Use and Indications for Use
-
- Non-inflammatory 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 or uncemented use.
Additional indications for Biomet G7 Freedom Constrained Liners:
The Biomet G7 Freedom Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: The proposed G7 Freedom and Offset Liners. Freedom Head, ● Size 32 devices have the same intended use.
- Indications for Use: The proposed G7 Freedom and Offset Liners, Freedom Head, Size 32 devices have the same indications for use.
- . Materials: The proposed acetabular liners are manufactured from UHMWPE per ASTM F648. The proposed acetabular liners in both ArComXL and E1 utilize the same material and manufacturing processes as the predicate liners in K121874,
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Image /page/5/Picture/1 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The word is likely a logo or brand name.
the G7 Acetabular System. The constrained liners incorporate the use of titanium alloy (ASTM F136) constraining rings, identical to the predicates. The Freedom Head, Size 32, is manufactured from wrought cobalt chrome, ASTM F1537.
- . Design Features: The design features of the proposed liners are the same as those of the Biomet predicates and similar to the S-ROM Constrained Liners. The Freedom Head, Size 32, is similar to the previously cleared size 36 Freedom Head, with the exception of a design change to the circumferential flats to accommodate the smaller size.
- Sterilization: The proposed devices and the predicates are provided sterile via . the same sterilization methods for single use.
Summary of Performance Data (Nonclinical and/or Clinical)
The mechanical tests and engineering analyses demonstrate the G7 Freedom and Offset Liners, Freedom Head, Size 32, are substantially equivalent to the predicate devices. No animal or clinical testing was required to support substantial equivalence. A description of the tests is located below.
- Axial Pull-out Test (Freedom Head)
- Lever-out Test (Freedom Head) .
- o Vertical Load Fatique Test (Poly Liners)
Since the internal design, materials and locking mechanism of the acetabular liners are the same as the G7 liners cleared in K121874, the non-clinical testing submitted for K121874 can be used as justification for the performance of the new G7 liners.
Substantial Equivalence Conclusion
The proposed G7 Freedom and Offset Liners and the Freedom Head, Size 32mm, have the same intended use and identical or similar indications for use as the predicate devices. Performance test data and analyses demonstrate the devices to be as safe and effective as the legally marketed predicate devices, indicating the G7 Freedom and Offset Liners and the Freedom Head, Size 32mm, substantially equivalent to the predicates.