(30 days)
The Unitrax® Modular Unipolar System is intended to be used with a Howmedica Osteonics hip stem. When assembled to a hip stem, the resultant component functions in Ostcomes imp stem. "When assemmooprosthesis. The endoprosthesis is used as a hemia shillial for the following indications: femoral neck fractures, idiopathic avascular necrosis and non-unions.
The Unitrax® component is a unipolar head that accepts a neck adjustment adaptor or sleeve. The neck adjustment sleeve is then assembled to the trunnion of the desired Howmedica Osteonics femoral stem. The design modification to the unipolar head involves a reduction in the wall thickness and removal of the inner "ribs". The manufacturing process modification involves changing the size 45mm components from machined to cast parts which results in a material change from ASTM F1537 to ASTM F75. The modified component is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process in 510(k) #K902365. The Unitrax® Modular Unipolar Heads are manufactured from Vitallium® (CoCr) Alloy which conforms to ASTM standards F75 (cast) and F1537 (wrought). The intended use of the modified Unitrax® Modular Unipolar Heads is identical to that of the unmodified Unitrax® Modular Unipolar Heads.
This submission describes design, manufacturing process, and material modifications to the Unitrax® Modular Unipolar System, a unipolar hip implant component. The information provided does not contain details about acceptance criteria, device performance, or a study that uses statistical measures to evaluate performance. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing and material verification, rather than clinical performance or AI/software validation.
Therefore, many of the requested fields cannot be answered directly from the provided text.
Here's the breakdown of what can be extracted and what is not available, based purely on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics for device performance (e.g., accuracy, sensitivity, specificity). The acceptance criteria implicitly revolve around demonstrating substantial equivalence to the predicate device through design, material, and manufacturing process changes, and possibly mechanical testing (though specific results are not detailed).
- Reported Device Performance: No quantitative performance metrics are reported. The document states:
- "The modified component is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process in 510(k) #K902365."
- "The intended use of the modified Unitrax® Modular Unipolar Heads is identical to that of the unmodified Unitrax® Modular Unipolar Heads."
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Substantial equivalence to predicate device (K902365) | Device is substantially equivalent to the predicate device. |
| Mechanical integrity after design changes (wall thickness reduction, rib removal) | Not explicitly quantified, but substantial equivalence determination implies that any necessary testing (e.g., fatigue, static strength) passed. |
| Material change from F1537 to F75 for 45mm components | "The Unitrax® Modular Unipolar Heads are manufactured from Vitallium® (CoCr) Alloy which conforms to ASTM standards F75 (cast) and F1537 (wrought)." Implies materials meet their respective ASTM standards and are suitable. |
| No change in intended use | "The intended use of the modified Unitrax® Modular Unipolar Heads is identical to that of the unmodified Unitrax® Modular Unipolar Heads." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. This document is a 510(k) summary for modifications to an existing device, and such submissions often rely on bench testing (mechanical, material, etc.) rather than clinical test sets with human subjects, unless a major change in safety/effectiveness is suspected.
- Data Provenance: Not specified. Likely involves in-house laboratory testing of the device components.
- Retrospective or Prospective: Not applicable as no clinical study or human data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a mechanical implant; ground truth would relate to material properties and mechanical performance, established through engineering standards and testing, rather than expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication process is described as there is no clinical data or expert interpretation involved in the substantial equivalence argument presented.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a hip implant, not an AI or imaging device. No human readers or AI assistance are part of this device or its evaluation in the provided text.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hip implant, not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth in this context would likely be engineering standards and specifications (e.g., ASTM standards for materials, recognized test methods for mechanical strength, fatigue, etc.) that the modified device components must meet to demonstrate substantial equivalence and safety/effectiveness. No clinical ground truth (pathology, outcomes) is mentioned.
8. The sample size for the training set
- Not applicable. No training set is involved as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable. No training set or associated ground truth.
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014226
JAN 2 5 2002
Special 510(k) Summary - Device Modifications for the UNITRAX® MODULAR UNIPOLAR SYSTEM
| Proprietary Name: | Unitrax® Modular Unipolar System |
|---|---|
| Common Name: | Unipolar Head |
| Classification Name and Reference: | 888.3360Hip joint femoral (hemi-hip) metallic cemented or uncementedprosthesis. |
| Proposed Regulatory Class: | II |
| Device Product Code: | KWL |
| For Information Contact: | Jennifer A. Daudelin, Regulatory Affairs |
| Howmedica Osteonics Corp. | |
| 59 Route 17 | |
| Allendale, NJ 07401-1677 | |
| (201) 831-5379 | |
| Fax: (201) 760-8435 |
This Special 510(k) submission is intended to address design, manufacturing process, and material modifications to the Unitrax® Modular Unipolar System. The Unitrax® component is a unipolar head that accepts a neck adjustment adaptor or sleeve. The neck adjustment sleeve is then assembled to the trunnion of the desired Howmedica Osteonics femoral stem. The design modification to the unipolar head involves a reduction in the wall thickness and removal of the inner "ribs". The manufacturing process modification involves changing the size 45mm components from machined to cast parts which results in a material change from ASTM F1537 to ASTM F75. The modified component is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process in 510(k) #K902365. The Unitrax® Modular Unipolar Heads are manufactured from Vitallium® (CoCr) Alloy which conforms to ASTM standards F75 (cast) and F1537 (wrought). The intended use of the modified Unitrax® Modular Unipolar Heads is identical to that of the unmodified Unitrax® Modular Unipolar Heads.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 5 2002
Ms. Jennifer A. Daudelin Regulatory Affairs Howmedica Osteonics, Corporation 59 Route 17 Allendale, New Jersey 07401-1677
Re: K014226
Trade/Device Name: Unitrax® Modular Unipolar System Regulation Number: 21 CFR 888.3360 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metallic Cemented or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWL Dated: December 21, 2001 Received: December 26, 2001
Dear Ms. Daudelin:
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.
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Page 2 - Ms Jennifer Daudelin
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
L. Mark N. Milburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
page 1 of 1
510(k) Number (if known):
Unitrax® Modular Unipolar System Device Name:
Indications for Use:
The Unitrax® Modular Unipolar System is intended to be used with a Howmedica The Onlines hip stem. When assembled to a hip stem, the resultant component functions in Ostcomes imp stem. "When assemmooprosthesis. The endoprosthesis is used as a hemia shillial for the following indications: femoral neck fractures, idiopathic avascular necrosis and non-unions.
(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)
Mark N Millken (Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K014226
§ 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.