(29 days)
Not Found
No
The document describes a hip replacement system and its modifications, focusing on material, design features, and mechanical performance. There is no mention of AI or ML technology.
Yes
The device is indicated for use in hip replacement due to various medical conditions, which inherently defines it as a therapeutic device designed to treat or alleviate these conditions.
No
The device description indicates it is an acetabular shell, which is a prosthetic component for hip replacement, not a device used to diagnose a medical condition. Its intended use is for treatment of hip issues, not diagnosis.
No
The device description clearly states it is a modification to existing acetabular shells, which are physical implants made of titanium alloy. The changes described are physical modifications to the shell's design (cut-outs and screw holes).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is an "Exactech Hip System," specifically focusing on "InteGrip Acetabular and InteGrip Revision Acetabular Shells." These are physical implants used in hip replacement surgery.
- Intended Use: The intended use is for "primary surgery for hip replacement" and "revision of failed previous reconstructions." This involves surgical implantation, not laboratory testing of samples.
- Anatomical Site: The anatomical site is the "Hip," which is consistent with a surgical implant.
The device described is a surgical implant used directly within the body, not a test performed on samples outside the body.
N/A
Intended Use / Indications for Use
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
- Cemented femoral stems and cemented acetabular cups are intended for . cemented fixation only.
- · Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
- Femoral heads and endoprostheses are intended for use in cemented and . press-fit applications.
Product codes
LPH, LZO, KWZ, JDI
Device Description
The proposed InteGrip Acetabular and InteGrip Revision Acetabular Shells are modifications to the Novation Crown Cup with InteGrip acetabular shell devices cleared through premarket notification #K102975.
The predicate and proposed devices have the same intended use and basic fundamental scientific technology.
The modified devices share the following similarities with the predicate devices:
- . Indications for use
- . Design features (e.g., outer and inner geometries, constrained liner feature, apical i locking feature , anti-rotational feature, and product scope)
- . Material (titanium alloy)
- Shelf life (10 years) .
- Packaging and sterilization materials and processes (gamma radiation . sterilization to a sterility assurance level of 10th).
This submission proposes the following design change:
- Addition of cut-outs on the outer diameter to accommodate optional augment . attachments.
- . Addition of InteGrip Revision Acetabular Shells with 9 or 12 holes, depending on shell size, for additional adjunctive screw fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
skeletally mature individuals
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
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Summary of Performance Studies
The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed InteGrip Acetabular and InteGrip Revision Acetabular Shells to the predicate Novation Crown Cup with InteGrip acetabular shells:
- Engineering analyses to evaluate stress on shell with screw holes and cut-outs. .
- Evaluation to assess InteGrip Revision Acetabular Shell screw hole number and ● placement.
- Evaluation to assess cut-out placement on the acetabular shells. .
The results of engineering analyses demonstrate the proposed device is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
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
Exactech® InteGrip™ Acetabular Shells Special 510(k) - 510(k) Summary of Safety and Effectiveness
OCT 1 1 2012
Exactech, Inc. Sponsor: 2320 N.W. 66th Court Gainesville, FL 32653
Phone: (352) 377-1140 (352) 378-2617 Fax:
FDA Establishment Number 1038671
Amy Taulbee Contact: Regulatory Affairs Specialist
Date: September 11, 2012
Trade of Proprietary or Model Name(s): Exactech® InteGrip™ Acetabular Shell
Exactech® InteGrip™ Revision Acetabular Shell
Common Name: Total Hip Arthroplasty - Acetabular Components
Classification Name:
Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (CFR 888.3358, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, Class II, Product Code LPH)
Information on devices to which substantial equivalence is claimed:
Trade of Proprietary Model Name Manufacturer 510(k) Number Novation® Crown Cup™ with InteGrip™ K102975 Exactech, Inc
Indications for Use:
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
- Cemented femoral stems and cemented acetabular cups are intended for . cemented fixation only.
- · Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
1
Exactech® InteGrip™ Acetabular Shells Special 510(k) - 510(k) Summary of Safety and Effectiveness
- Femoral heads and endoprostheses are intended for use in cemented and . press-fit applications.
Device Description:
The proposed InteGrip Acetabular and InteGrip Revision Acetabular Shells are modifications to the Novation Crown Cup with InteGrip acetabular shell devices cleared through premarket notification #K102975.
The predicate and proposed devices have the same intended use and basic fundamental scientific technology.
The modified devices share the following similarities with the predicate devices:
- . Indications for use
- . Design features (e.g., outer and inner geometries, constrained liner feature, apical i locking feature , anti-rotational feature, and product scope)
- . Material (titanium alloy)
- Shelf life (10 years) .
- Packaging and sterilization materials and processes (gamma radiation . sterilization to a sterility assurance level of 10th).
This submission proposes the following design change:
- Addition of cut-outs on the outer diameter to accommodate optional augment . attachments.
- . Addition of InteGrip Revision Acetabular Shells with 9 or 12 holes, depending on shell size, for additional adjunctive screw fixation.
Substantial Equivalence Conclusion:
The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed InteGrip Acetabular and InteGrip Revision Acetabular Shells to the predicate Novation Crown Cup with InteGrip acetabular shells:
- Engineering analyses to evaluate stress on shell with screw holes and cut-outs. .
- Evaluation to assess InteGrip Revision Acetabular Shell screw hole number and ● placement.
- Evaluation to assess cut-out placement on the acetabular shells. .
The results of engineering analyses demonstrate the proposed device is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT
11
2012
Exactech. Inc. % Ms. Amy Taulbee Regulatory Affairs Specialist 2320 N.W. 66th Court Gainesville, Florida 32653
Re: K122798
K122796
Trade/Device Name: Exactech InteGrip Acetabular Shell, Exactech InteGrip Revision Acetabular Shell
Regulation Number: 21 CFR 888.3358
Regulation Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis
Regulatory Class: II Product Codes: LPH, LZO, KWZ, JDI Dated: September 11, 2012 Received: September 12, 2012
Dear Ms. Taulbee:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications forcenced in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreated of the enactment date of the Medical Device Amendments, or to conninered prices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de nees that hat to been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, cherely mains 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 adulteration. Trease now, 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 may of subject to additions, 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 I lease be devilsed that I Dr i resumes of your device complies with other requirements of the Act that I Dri has made a actorized administered by other Federal agencies. You must or any I odolar battler and a media ments, including, but not limited to: registration and listing (21
3
Page 2 - Ms. Amy Taulbee
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours.
-Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exactech® InteGrip™ Acetabular Shells Special 510(k) - Indications for Use
510(k) Number: K122798
Device Name: Exactech® InteGrip™ Acetabular Shells
INDICATIONS
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
- Cemented femoral stems and cemented acetabular cups are intended for . cemented fixation only.
- Press-fit femoral stems and acetabular cups are intended for press-fit fixation. .
- Femoral heads and endoprostheses are intended for use in cemented and . press-fit applications.
Prescription Use X (Part 21 CFR 801 Subpart D) and/or
Over-The-Counter Use (21 CFR 807 Subpart C)
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter G. Oblein for Anton Dmitriev
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122798