(149 days)
The MODULAR-PLUS® Revision Stem is intended for cementless use in fractures of the femur where a long section of bone is damaged and the stem must anchor into the distal half of the femur.
The MODULAR-PLUS Revision Stem is a cement-less, two-part modular system that consists of a distal anchorage module and a proximal revision module. These two modules are connected with a multi-staged conical coupling and fitted with a safety screw. Taken together, the two modules again form a long, quadrilateral, conical stem prosthesis, which can be anchored in the distal half of the femur. The range consists of 12 distal and 6 proximal modules of various sizes. The distal module has a symmetrical curve matching the forward curve of the femur, suitable for the right and left femur. The proximal module offers a choice of standard and long modules in order to achieve the appropriate geometry of the stem and acetabulum. It is placed on top of the firmly embedded distal module and is fully adjustable to the appropriate degree of anteversion. Both modules (proximal and distal) and the safety screw are made of titanium (TiAl6Nb7) in conformance with ASTM-F 1295-92 and ISO 5832-11.
The provided text describes a medical device, the MODULAR-PLUS Revision Stem, and its FDA 510(k) clearance. However, it does not contain the specific information required to complete the requested table and study details.
The document states: "Performance data: Biomechanical Testing has been provided." but it does not include the actual results of this testing, nor does it specify acceptance criteria for the device's performance.
Therefore, I cannot fulfill the request as there is no data in the input text regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory approval letter based on "substantial equivalence" to a predicate device, not a detailed technical report of the device's performance studies.
{0}------------------------------------------------
October 15, 1999
MAY - 4 2000
- Trade name: MODULAR-PLUS Revision Stem
- Common name: Hip Stem Prosthesis
- Classification name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis 21 CFR 888.3360 (87) בעיק
Equivalence: LINK MP Reconstruction Hip Stem (K-955296, SE date 02/14/96)
- Characteristics: The MODULAR-PLUS Revision Stem is a cement-less, two-part modular system that consists of a distal anchorage module and a proximal revision module. These two modules are connected with a multi-staged conical coupling and fitted with a safety screw. Taken together, the two modules again form a long, quadrilateral, conical stem prosthesis, which can be anchored in the distal half of the femur. The range consists of 12 distal and 6 proximal modules of various sizes. The distal module has a symmetrical curve matching the forward curve of the femur, suitable for the right and left femur. The proximal module offers a choice of standard and long modules in order to achieve the appropriate geometry of the stem and acetabulum. It is placed on top of the firmly embedded distal module and is fully adjustable to the appropriate degree of anteversion. Both modules (proximal and distal) and the safety screw are made of titanium (TiAl6Nb7) in conformance with ASTM-F 1295-92 and ISO 5832-11.
- Indications: The MODULAR-PLUS Revision Stem is intended for use in fractures of the femur where a long section of bone is damaged and the stem must anchor into the distal half of the femur.
- Contraindications: Contraindications include acute or chronic infections (local or systemic), serious lesions of muscles, nerves or blood vessels, which put the affected limb at risk, bony defects or poor bone quality, which might endanger the stability of the prosthesis, and any concurrent disease, which might interfere with the function of the implant.
- Performance data: Biomechanical Testing has been provided.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2000
Mr. Hartmut Loch Chief Executive Officer Plus Orthopedics Building 15-100 3550 General Atomics Court San Diego, California 92121-1122
Re: K994126
Trade Name: Modular-Plus® Revision Stem Regulatory Class: II Product Code: LWJ Dated: March 3, 2000 Received: March 3, 2000
Dear Mr. Loch:
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 control 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 (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 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 - Mr. Hartmut Loch
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,
e R. lochner.
Celia M. Witten, Ph.D., M.D. S Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Page 1 of 1
510(k) Number (if known): K994126
MODULAR-PLUS® Revision Stem Device Name:
Indications for Use:
The MODULAR-PLUS® Revision Stem is intended for cementless use in fractures of the femur where a long section of bone is damaged and the stem must anchor into the distal half of the femur.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) ுvision of General Restorative Devices 510(k) Number K99412 6
Prescription Use n (Per 21 CFR 801.109)
No Over-The-Counter-Use
(Optional Format 1-2-96)
§ 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.