(62 days)
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No
The 510(k) summary describes a mechanical implant component (adaptor sleeve) made of cobalt chromium alloy. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The device's function is purely mechanical.
Yes
The device is described as an "adaptor sleeve" for "Hemi-Hip Replacement" and is indicated for conditions like "Femoral head/neck fractures," "Aseptic necrosis of the femoral head," and "Osteo-, rheumatoid, and post traumatic arthritis of the hip," all of which are treated with therapeutic interventions to alleviate symptoms or restore function.
No
The provided text explicitly states that the device is a "UniPolar Adaptor Sleeve" used in "Hemi-Hip Replacement" and "salvage of failed total hip arthroplasty." This indicates it is a surgical implant component, not a device used for diagnosis.
No
The device description explicitly states it is composed of cobalt chromium alloy and is a physical component designed to function with other physical components (femoral stems and endo heads). It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (an adaptor sleeve for a hip replacement). Its intended use is for surgical procedures to replace parts of the hip joint due to various conditions like fractures, necrosis, or arthritis.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient. The device is directly implanted into the body.
Therefore, based on the provided information, the Osteonics +10 UniPolar Adaptor Sleeve is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Osteonics +10 UniPolar Adaptor Sleeve is a single-use device and may be used with all appropriately selected, legally marketed Osteonics C-Taper Femoral Stems and with any size Osteonics legally marketed +0 mm Unipolar Endo Heads (Single-Piece Unipolar Design).
For Use as a Hemi-Hip Replacement:
- Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
- Pathological conditions or age considerations which indicate a more conservative acetabular procedure and in avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
KWL, KWY
Device Description
Osteonics +10 UniPolar Adaptor Sleeve is composed of cobalt chromium alloy and is designed to function with any size Osteonics +0 Unipolar Endo Head (Single-Piece Unipolar Design) and any Osteonics C-Taper Femoral Stem. The Osteonics +10 UniPolar Adaptor Sleeve is designed with both a male and a female C-taper. The female end receives the femoral stem and the male end engages the Endo Head.
The Osteonics +10 UniPolar Adaptor Sleeve is characterized by the following features:
- A basic taper design.
- A smooth exterior finish.
- Constructed of material that has a long history of orthopedic use.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
§ 888.3360 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
2/24/99
Osteonics® +10 Unipolar Adaptor Sleeve
510(k) Summary
510(k) Premarket Notification Summary of Safety and Effectiveness
Osteonics® +10 UniPolar Adaptor Sleeve
Submission Information
Name and Address of the Sponsor of the 510(k) Submission: 59 Route 17
Contact Person:
Date of Summary Preparation:
Device Identification
Proprietary Name:
Common Name:
Classification Name and Reference:
Howmedica Osteonics Corp. Allendale, NJ 07401-1677
Marybeth Naughton Regulatory Affairs Team Member
December 23, 1998
Osteonics +10 UniPolar Adaptor Sleeve
Prosthesis Hip, Hemi-, Femoral, Metal/Polymer Cemented or Uncemented 21 CFR §888.3390
Predicate Device Identification
The Osteonics +10 UniPolar Adaptor Sleeve is substantially equivalent to the following competitive and/or Osteonics' devices, which have previously been determined substantially equivalent by FDA:
- Howmedica Unitrax Unipolar Neck Adjustment Sleeve Component
- Osteonics® Neck Extension for Modular Endo head
1
Device Description
Osteonics +10 UniPolar Adaptor Sleeve is composed of cobalt chromium alloy and is designed to function with any size Osteonics +0 Unipolar Endo Head (Single-Piece Unipolar Design) and any Osteonics C-Taper Femoral Stem. The Osteonics +10 UniPolar Adaptor Sleeve is designed with both a male and a female C-taper. The female end receives the femoral stem and the male end engages the Endo Head.
The Osteonics +10 UniPolar Adaptor Sleeve is characterized by the following features:
- · A basic taper design.
- · A smooth exterior finish.
- · Constructed of material that has a long history of orthopedic use.
Intended Use:
The Osteonics +10 UniPolar Adaptor Sleeve is a single-use device and may be used with all appropriately selected, legally marketed Osteonics C-Taper Femoral Stems and with any size Osteonics legally marketed +0 mm Unipolar Endo Heads (Single-Piece Unipolar Design).
Indications :
For use as a Hemi-Hip Replacement:
The indications for the use of Osteonics +10 UniPolar Adaptor Sleeve, in keeping with those of other legally marketed Osteonics Hemi-Hip Replacement components, are as follows:
For Use as a Hemi-Hip Replacement:
- . Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
Other Considerations:
- Pathological conditions or age considerations which indicate a more conservative acetabular procedure and in avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty.
2
Statement of Technological Comparison:
The substantial equivalence of the Osteonics +10 UniPolar Adaptor Sleeve to the predicate devices identified above-in terms of intended use, materials, and design features-is based on the following.
Intended Uses:
The Osteonics, +10 UniPolar Adaptor Sleeve, like the predicate devices cited above, is intended for use with appropriately selected, legally marketed components for Hemi-Hip replacement.
Materials:
The Osteonics +10 UniPolar Adaptor Sleeve and the predicate devices cited above are manufactured from the same material - cobalt chromium alloy. The materials used in the subject device and the predicate devices are not new and have been used for orthopedic applications including hemi-hip replacement in the United States and Europe for many years.
Design:
The design of the Osteonics +10 UniPolar Adaptor Sleeve is consistent with that of the predicate devices and differs in the following:
- The Howmedica Unitrax Unipolar Neck Adjustment Sleeve Components are ー available in four sizes while the subject device is available in only one size.
- -The Howmedica Unitrax Unipolar Neck Adjustment Sleeve Components differs in dimensional specifications from the subject device. This is consistent with the use of the predicate and subject device in that each is specifically designed with dimensions to accommodate each company's accessory components.
- ー The Osteonics" Neck Extension for Modular Endo Head is available in three sizes while the subject device is available in only one size.
- -The Osteonics Neck Extension for Modular Endo Head differs in dimensional specifications from the subject device. This is consistent with the use of the predicate and subject device in that each is specifically designed with dimensions to accommodate appropriate Osteonics legally marketed accessory components.
None of these design differences raises any new questions of safety or effectiveness.
Summarv
Based on the similarities and differences presented above, the supporting testing summary, the pre-clinical data incorporated by reference to prior submissions, and the fact that the Osteonics +10 UniPolar Adaptor Sleeve employs standard sterilization and packaging methods, the substantial equivalence of the Osteonics +10 UniPolar Adaptor Sleeve to other legally marketed, class II, components is demonstrated.
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Image /page/3/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 1999
Ms. Elizabeth A. Staub Vice President, Quality Assurance/Regulatory Compliance/Clinical Research Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey
Re: K984585 Osteonics® +10 UniPolar Adaptor Sleeve Trade Name: Requlatory Class: II Product Codes: KWL and KWY December 23, 1998 Dated: December 24, 1998 Received:
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 aqainst 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 Requlations, 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 (QS) 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 In addition, FDA may publish further announcements action. 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 requlations.
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Page 2 - Ms. Elizabeth A. Staub
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.
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 (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
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510(k) Number (if known): K 984585
Device Name: Osteonics +10 UniPolar Adaptor Sleeve
Indications For Use:
The indications for use of the Osteonics +10 UniPolar Adaptor 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. ●
- Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular ● involvement or distortion.
Other Considerations:
- Pathological conditions or age considerations which indicate a more conservative ● acetabular procedure and in avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty. ●
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
tecotel
(Optional Format 1-2-96)
Division Sign-Off
Division of General Resporative Devices 510(k) Number