(29 days)
Not Found
No
The 510(k) summary describes a mechanical implant (acetabular augments) and its design modifications. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance study is an engineering evaluation of geometric features.
Yes.
The device is an acetabular augment used in hip replacement surgery, which is a therapeutic intervention for segmental acetabular deficiencies.
No
This device is an acetabular augment, used in hip replacement surgery to address segmental acetabular deficiencies. Its purpose is to physically reconstruct or augment the hip joint, not to diagnose a condition.
No
The device description clearly states the device is a physical implant made of titanium alloy, intended for surgical implantation. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Exactech Novation InteGrip Acetabular Augments are implants used in hip replacement surgery to address acetabular deficiencies. They are physical components implanted into the body, not devices used to analyze samples outside the body.
- No Mention of Samples or Testing: The text does not mention any analysis of biological samples or diagnostic testing.
Therefore, this device falls under the category of an implantable medical device used in surgery, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip replacement and whose orthopedic surgeon desires a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.
The Exactech Novation InteGrip Acetabular Augment is affixed to the mating acetabular shell using PMMA bone cement. Therefore, acetabular shells with HA coating must not be used with InteGrip Acetabular Augments. The assembled construct is intended for press-fit fixation.
Product codes (comma separated list FDA assigned to the subject device)
LPH
Device Description
The proposed Exactech Novation InteGrip Acetabular Augments are a modification of the Exactech InteGrip Acetabular Augments cleared through premarket notification #K101761.
The predicate and proposed devices have the same intended use and the same basic fundamental scientific technology.
The modified devices share the following similarities with predicate devices:
. Indications for Use
Design Features (e.g. screw holes, height configurations)
Material (titanium alloy) .
. Shelf Life (5 years)
Packaging and sterilization materials and processes (gamma radiation sterilization to a sterility assurance level of 10°)
The proposed devices include the following design change:
Expand the current scope of augments to include sizes that are compatible with . the Novation Crown Cup acetabular shell sizes 60-68mm (both plasma spray and InteGrip).
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
Orthopedic surgeon
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)
Engineering analyses were conducted to demonstrate substantial equivalence of the proposed device to the predicate Exactech Novation InteGrip Acetabular Augments.
An engineering evaluation was conducted to determine that the geometric features of the proposed devices correspond to the compatible acetabular shells and are dimensionally and functionally similar to the predicate devices.
The results of engineering analyses demonstrate the proposed device is substantially equivalent to the predicate 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.
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
§ 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.
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Exactech® Novation® InteGrip™ Acetabular Augments Special 510(k) - 510(k) Summary of Safety and Effectiveness
Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, FL 32653
Phone: (352) 377-1140 Fax: (352) 378-2617
FDA Establishment Number 1038671
Vladislava Zaitseva Contact: Regulatory Affairs Specialist
Date: January 4, 2012
Trade or Proprietary or Model Name(s): Exactech® Novation® InteGrip™ Acetabular Augments
Common Name: Acetabular Augment
Classification Name:
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (21 CFR 888.3358, Device Class: II, Product Code: LPH)
Information on devices to which substantial equivalence is claimed: 510/k) Number Trade or Proprietary or Model Name
| 510(K) Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K101761 | Exactech Novation InteGrip Acetabular Augments | Exactech, Inc |
Indications for Use:
The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip replacement and whose orthopedic surgeon desires a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.
The Exactech Novation InteGrip Acetabular Augment is affixed to the mating acetabular shell using PMMA bone cement. Therefore, acetabular shells with HA coating must not be used with InteGrip Acetabular Augments. The assembled construct is intended for press-fit fixation.
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K113609 Page 2/2
Exactech® Novation® InteGrip™ Acetabular Augments Special 510(k) - 510(k) Summary of Safety and Effectiveness
Device Description:
The proposed Exactech Novation InteGrip Acetabular Augments are a modification of the Exactech InteGrip Acetabular Augments cleared through premarket notification #K101761.
The predicate and proposed devices have the same intended use and the same basic fundamental scientific technology.
The modified devices share the following similarities with predicate devices:
- . Indications for Use
- Design Features (e.g. screw holes, height configurations) �
- Material (titanium alloy) .
- . Shelf Life (5 years)
- Packaging and sterilization materials and processes (gamma radiation sterilization to a sterility assurance level of 10°)
The proposed devices include the following design change:
- Expand the current scope of augments to include sizes that are compatible with . the Novation Crown Cup acetabular shell sizes 60-68mm (both plasma spray and InteGrip).
Substantial Equivalence Conclusion:
The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed device to the predicate Exactech Novation InteGrip Acetabular Augments:
- An engineering evaluation to determine that the geometric features of the . proposed devices correspond to the compatible acetabular shells and are dimensionally and functionally similar to the predicate devices.
In addition to the design similarities, the results of engineering analyses demonstrate the proposed device is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JAN - 4 2012
Exactech® Inc. % Ms. Vladislava Zaitseva 2320 N.W. 66th Court Gainesville, FL 32653
Re: K113609
Trade/Device Name: Exactech® Novation® InteGrip™ Acetabular Augments Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: December 5th, 2011 Received: December 6ta, 2011
Dear Ms. Zaitseva:
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.
3
Page 2 - Ms. Vladislava Zaitseva
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 (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 yours,
Einol Keith
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 Augments Special 510(k) - Indications for Use
510(k) Number:
Device Name: Exactech® InteGrip™ Acetabular Augments
INDICATIONS
The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip replacement and whose orthopedic surgeon desires a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.
The Exactech Novation InteGrip Acetabular Augment is affixed to the mating acetabular shell using PMMA bone cement. Therefore, acetabular shells with HA coating must not be used with InteGrip Acetabular Augments. The assembled construct is intended for press-fit fixation.
| 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)
BBRS Lr
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113609