(30 days)
Not Found
No
The document describes a mechanical orthopedic implant component and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a component of an acetabular cup system intended for hip replacement surgery, specifically for patients at high risk of hip dislocation. Its function is primarily to stabilize the hip joint, which is a structural and mechanical intervention rather than a therapeutic one (e.g., drug delivery, disease treatment).
No
This device is an implantable component for hip replacement surgery, designed to reduce the risk of dislocation. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (liners and rings made of specific materials with defined geometries) intended for surgical implantation in the hip joint. There is no mention of software as the primary or sole component.
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 device for surgical implantation in the hip joint to address issues like dislocation and instability. This is a therapeutic and structural device, not a diagnostic one.
- Device Description: The description details physical components (liners and rings) made of materials like titanium, designed to fit within an acetabular cup system. This aligns with a medical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies mentioned are engineering evaluations to verify the structural integrity and function of the implant, not studies related to diagnostic accuracy.
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.
N/A
Intended Use / Indications for Use
Novation Crown Cup ™ Constrained Liners and Rings are components of the Exactech Novation® non-cemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and are compatible with Exactech press-fit or cemented femoral stem components.
Product codes
KWZ
Device Description
The proposed Novation® Constrained Acetabular Liners are modifications of the previously cleared AcuMatch A-Series predicates. The design features of the subject devices are summarized below:
NOVATION CONSTRAINED LINERS
- Sphere and taper inner diameter geometry for compatibility with the Novation . Crown Cup
- Increased range-of-motion and lever-out moment by decreasing the height of the . constraining petals, increasing the constraining diameter and increasing the lead in chamfer
- Addition of a 36mm ID option. .
NOVATION CONSTRAINED RINGS
- The constraining ring will be made of Ti-6Al-4V per ASTM F1472 instead of Ti- 6Al-4V per ASTM F136.
- Ring snaps into a locking feature on the Novation Crown Cup instead of press-. fit.
- Inner and outer diameter of the constraining ring modified for compatibility with . the proposed constrained liner and Novation Crown Cup.
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)
Engineering evaluations were conducted to verify that the performance of the proposed acetabular components would be adequate for anticipated in vivo use. Based on successful results discussed in this submission, we conclude that the proposed devices are substantially equivalent to the previously cleared predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”
0
K071676
Exactech® Novation Crown Cup TM Constrained Liners and Rings Special 510(k) - 510(k) Summary
Trade or proprietary or model name(s): Novation Crown Cup TM Constrained Liners and Rings
JUL 1 9 2007
Common Name Constrained Liners and Rings
Classification name
Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR Section 888.3310)
Information on devices to which substantial equivalence is claimed:
| 510(k)
| Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| #K040601 | AcuMatch A-Series & MCS Constrained Liners | Exactech. Inc. |
Indications for Use:
Novation Crown Cup ™ Constrained Liners and Rings are components of the Exactech Novation® non-cemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and are compatible with Exactech press-fit or cemented femoral stem components.
Device Description:
The proposed Novation® Constrained Acetabular Liners are modifications of the previously cleared AcuMatch A-Series predicates. The design features of the subject devices are summarized below:
NOVATION CONSTRAINED LINERS
- Sphere and taper inner diameter geometry for compatibility with the Novation . Crown Cup
- Increased range-of-motion and lever-out moment by decreasing the height of the . constraining petals, increasing the constraining diameter and increasing the lead in chamfer
- Addition of a 36mm ID option. .
NOVATION CONSTRAINED RINGS
- The constraining ring will be made of Ti-6Al-4V per ASTM F1472 instead of Ti-� 6Al-4V per ASTM F136.
1
KO71676 Exactech® Novation Crown Cup ™ Constrained Liners and Rings Special 510(k) - 510(k) Summary
(89 2 of 2
- Ring snaps into a locking feature on the Novation Crown Cup instead of press-. fit.
- Inner and outer diameter of the constraining ring modified for compatibility with . the proposed constrained liner and Novation Crown Cup.
Substantial Equivalency Conclusion:
Engineering evaluations were conducted to verify that the performance of the proposed acetabular components would be adequate for anticipated in vivo use. Based on successful results discussed in this submission, we conclude that the proposed devices are substantially equivalent to the previously cleared predicates.
2
Image /page/2/Picture/12 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of what appears to be an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Exactech, Inc. % Mr. Graham Cuthbert Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653
JUL 1 9 2007
Re: K071676
Trade/Device Name: Novation Crown Cup™ Constrained Liners and Rings Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWZ Dated: June 15, 2007 Received: June 19, 2007
Dear Mr. Cuthbert:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 (21 CFR Part 807); labeling (21 CFR Part 801); 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.
3
Page 2 - Graham Cuthbert
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Barbara Buehrig
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exactech® Novation Crown Cup ™ Constrained Liners and Rings Special 510(k) - Indications for Use
| 510(k) Number: | K071676 |
|---|---|
| Device Name: | Exactech Novation Crown Cup TM Constrained Liners and Rings |
| Intended Use: | Exactech Novation Crown Cup TM Constrained Liners and Rings are components of the Exactech Novation® non-cemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and are compatible with Exactech press-fit or cemented femoral stem components. |
| Prescription Use | |
| (Part 21 CFR 801 Subpart D) | X 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)
Charlane Bovehir
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K071671
Section 5 Page 1 of 1