(30 days)
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No
The device description focuses on a mechanical component (a neck adjustment sleeve) and its material properties and compatibility with other components. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for use as a hemi-hip replacement to treat medical conditions like femoral head/neck fractures, aseptic necrosis, osteo- and post-traumatic arthritis, which are therapeutic interventions.
No
The device is described as a component for a hemi-hip replacement, designed to connect a unipolar head to a femoral stem. Its purpose is to physically reconstruct a hip joint, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a physical component ("tapered sleeve component") made from a specific material ("wrought cobalt-chromium alloy").
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for hemi-hip replacement to address issues with the femoral head/neck. This is a therapeutic and structural device, not a diagnostic one.
- Device Description: The description details a physical component (a sleeve) made of a metal alloy, designed to connect parts of a hip implant. This is consistent with a medical device used in surgery, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis.
Therefore, the Unitrax® C-Taper Neck Adjustment Sleeve is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use of the Unitrax® C-Taper Neck Adjustment Sleeve, in keeping with those of the legally marketed predicate devices, are as follows:
For Use as a Hemi-Hip Replacement:
- Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head/neck
- Osteo- and post traumatic arthritis
Product codes
KWL
Device Description
This Special 510(k) submission is intended to address a design modification to the predicate Unitrax® V40™ Neck Adjustment Sleeve. The Unitrax® V40™ Neck Adjustment Sleeve is a tapered sleeve component whose outer diameter mates with the bore of the Unitrax® Unipolar Head, and inner diameter mates with the trunnion neck of the femoral stem. The design modification involves changing the inner taper diameter of the current sleeve component. The modified device will allow Unitrax® Unipolar Heads to be compatible with Osteonics C-Taper femoral stems. The modified component, the Unitrax® C-Taper Neck Adjustment Sleeve, is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process. The Unitrax® C-Taper Neck Adjustment Sleeves are manufactured from wrought cobaltchromium alloy, which conforms to ASTM F-1537. The intended use of the subject Unitrax® C-Taper Neck Adjustment Sleeve is identical to that of the Unitrax® V40™ Neck Adjustment Sleeve.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
0
SEP
Unitrax® C-Taper Neck Adjustment Sleeve
Snecial 511
Special 510(k) Summary - Device Modification Summary of Safety and Effectiveness for the Unitrax® C-Taper Neck Adjustment Sleeve
Unitrax® C-Taper Neck Adjustment Sleeve Proprietary Name: Adaptor for Unipolar Head Common Name: Hip joint femoral (hemi-hip) metallic cemented or Classification Name and Reference: uncemented prosthesis, 21 CFR §888.3360 Class II Proposed Regulatory Class: 87 KWL Device Product Code: Karen Ariemma, Regulatory Affairs Specialist For Information contact: Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 (201) 760-8187 Fax: (201) 934-4368
This Special 510(k) submission is intended to address a design modification to the predicate Unitrax® V40™ Neck Adjustment Sleeve. The Unitrax® V40™ Neck Adjustment Sleeve is a tapered sleeve component whose outer diameter mates with the bore of the Unitrax® Unipolar Head, and inner diameter mates with the trunnion neck of the femoral stem. The design modification involves changing the inner taper diameter of the current sleeve component. The modified device will allow Unitrax® Unipolar Heads to be compatible with Osteonics C-Taper femoral stems. The modified component, the Unitrax® C-Taper Neck Adjustment Sleeve, is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process. The Unitrax® C-Taper Neck Adjustment Sleeves are manufactured from wrought cobaltchromium alloy, which conforms to ASTM F-1537. The intended use of the subject Unitrax® C-Taper Neck Adjustment Sleeve is identical to that of the Unitrax® V40™ Neck Adjustment Sleeve.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 1 1999
Ms. Elizabeth A. Staub Vice President Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401
Re: K992570
Trade Name: Unitrax C-Taper Neck Adjustment Sleeve Regulatory Class: II Product Code: KWL Dated: July 30, 1999 Received: August 2, 1999
Dear Ms. Staub:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
2
Page 2 – Ms. Elizabeth A. Staub
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number (if known): K995-7 0
Device Name: Unitrax® C-Taper Neck Adjustment Sleeve
Indications For Use:
. ﺗ
The indications for use of the Unitrax® C-Taper Neck Adjustment Sleeve, in keeping with those of the legally marketed predicate devices, are as follows:
For Use as a Hemi-Hip Replacement:
- Femoral head/neck fractures or non-unions. ●
- Aseptic necrosis of the femoral head/neck ●
- Osteo- and post traumatic arthritis ●
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Yes
OR
Over-The-Counter Use No
(Optional Format 1-2-96)
(Division Sign-Off) Division of General Restorative Device 510(k) Number
(Per 21 CFR 801.109)
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