(268 days)
No
The summary describes a hip implant system with porous acetabular shells and femoral stems, focusing on material properties, mechanical testing, and compatibility with existing components. 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 for conditions like osteoarthritis, rheumatoid arthritis, and bone fractures, all of which aim to treat medical conditions and restore function.
No
This device is an acetabular shell, which is a component of a total hip prosthesis. It is an implanted medical device used for treatment, not for diagnosing a condition.
No
The device description clearly details physical components made of titanium alloy powder, including acetabular shells with porous regions and specific locking mechanisms, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The indications clearly describe a device used in vivo (within the body) for surgical procedures related to joint replacement and repair. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical implantable device (acetabular shells) designed for biological fixation within the hip joint. This is consistent with a surgical implant, not an IVD.
- Mentions image processing, AI, DNN, ML, Input Imaging Modality: The absence of these terms further supports that this is not a device that processes or analyzes biological samples or medical images for diagnostic purposes.
- Anatomical Site: The hip is an anatomical site where surgical implants are placed, not where IVD testing is typically performed.
- Performance Studies: The performance studies described are mechanical and material characterization tests relevant to the physical properties and biological integration of an implant, not analytical performance studies typical for IVDs (like sensitivity, specificity, etc.).
In summary, the device is a surgical implant intended for use within the body to treat various hip conditions. This falls outside the definition and typical characteristics of an In Vitro Diagnostic device.
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 or uncemented use.
Product codes
LPH, LZO, OQG, KWZ, JDI, OQH, OQI, PBI
Device Description
The G7 OssetoTi™ Acetabular Shells are part of the G7™ Acetabular System, designed to provide numerous options for surgeons and patients in one modular compatible system. The OsseoTi™ Shell utilizes an outer surface porous region produced by additive manufacturing using titanium alloy powder (ASTM F2924). This structure leads to a highly interconnected volume of porosity and promotes biological fixation through tissue ingrowth. The shell is available in either a limited hole or multi-hole design. The inner diameter and locking mechanisms are identical to the previously cleared shells of the G7™ Acetabular System, K121874, and will be compatible with the G7™ Acetabular System's E1™ and ArComXL™ polyethylene acetabular liners, as well as all modular components and instrumentation included in K121874.
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
None provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 22, 2015
Biomet, Incorporated Ms. Becky Earl Senior Regulatory Specialist P.O. Box 587 56 East Bell Drive Warsaw, Indiana 46581
Re: K140669
Trade/Device Name: G7 OsseoTi™ Acetabular Shells 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, OQH, OQI, PBI Dated: November 10, 2014 Received: November 12, 2014
Dear Ms. Earl:
This letter corrects our substantially equivalent letter of December 11, 2014.
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.
1
Page 2 - Ms. Becky Earl
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); 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 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. 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,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K140669
Device Name: G7 OsseoTi™ Acetabular Shells
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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR AND/OR AND/OR Over-The-Counter Use NO (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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Image /page/3/Picture/0 description: The image shows the logo for BIOMET INC. The logo is in a sans-serif font and is all caps. The letters are all connected and are in a light gray color. The logo is simple and modern.
510(k) Summary
| Preparation Date: | December 10, 2014 |
|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corp. |
| 56 East Bell Drive | |
| P.O. Box 587 | |
| Warsaw, IN 46581-0587 | |
| Establishment Registration Number: 1825034 | |
| Contact Person: | Becky Earl |
| Senior Regulatory Specialist | |
| 574-372-1518 | |
| Fax: 574-372-1683 | |
| Proprietary Name: | G7 OsseoTi™ Acetabular Shells |
| Common Name: | Acetabular Shells |
| 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) |
Mailing Address:
Mailing Address:
P.O. Box 587 Warsaw, IN 46581-0587
Toll Free: 800.348.95000
Office: 5748.348.95000
Office: 574.267.8139.8131.8131.8131
Www.biomet.com Shipping Address:
56 East Bell Drive Warsaw, IN 46582
4
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
G7 Acetabular System—K121874 (Biomet) Exactech Novation Crown Cup with InteGrip-K102975 and K122798 (Exactech)
Reference predicates include K122770, Biomet Reconstructive Wedges, which first introduced Biomet's additive manufacturing process and Regenerex Porous Titanium Acetabular Shells. K052996. which served as a comparison in unsupported fatigue testing.
Device Description:
The G7 OssetoTi™ Acetabular Shells are part of the G7™ Acetabular System, designed to provide numerous options for surgeons and patients in one modular compatible system. The OsseoTi™ Shell utilizes an outer surface porous region produced by additive manufacturing using titanium alloy powder (ASTM F2924). This structure leads to a highly interconnected volume of porosity and promotes biological fixation through tissue ingrowth. The shell is available in either a limited hole or multi-hole design. The inner diameter and locking mechanisms are identical to the previously cleared shells of the G7™ Acetabular System, K121874, and will be compatible with the G7™ Acetabular System's E1™ and ArComXL™ polyethylene acetabular liners, as well as all modular components and instrumentation included in K121874.
Indications for Use:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 1.
-
- Rheumatoid arthritis.
- Correction of functional deformity. 3.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with 4. 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 Technologies:
The technological characteristics of the proposed devices, produced by additive manufacturing, are the same as or similar to the predicates. The outer porous structure of the OsseoTi™ shell is manufactured similarly to the Exactech Novation Crown Cup with InteGrip. The inner shell incorporates the G7™ acetabular shell design, dimensions, locking mechanisms, and intended use.
Non-Clinical Testing:
Previous testing was completed on the G7" Acetabular System, K121874, to support substantial equivalence. The testing is applicable to the OsseoTi™ Shells as the sizing and mating features are identical.
5
New Testing on G7 OsseoTi™ Acetabular Shells:
- Deformation Testing .
- Torsional Testing
- . Fatigue Testing (both anatomic and unsupported fatigue)
- Poly Push Out Testing .
- Poly Lever Out Testing
- Poly Torque Out Testing ●
OsseoTi™ Material Characterization:
- Chemical Composition
- . Interconnected Porosity
- Average Pore Size
- Porosity Volume ●
- Roughness ●
- Tensile Adhesion
- Abrasion Resistance
- . Static Shear Strength
- Shear Fatigue ●
- Compressive Strength ●
- . Elastic Modulus
Other:
- . Animal Data
Clinical Testing:
None provided as a basis for substantial equivalence.
The culmination of the results of the mechanical testing, OsseoTi characterization and animal data indicate that the devices perform within the intended use and are substantially equivalent to the predicate devices.