(78 days)
The Maestro™ Carpal HemiArthroplasty is indicated for use as a replacement of wrist joints disabled by pain, deformity and/or limited motion caused by:
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis
- Rheumatoid arthritis
- Revision where other devices or treatments have failed
- Scapholunate Advanced Collapse (SLAC) and other functional deformities
- Trauma, including fractures of the carpal bones
The device is intended to be implanted with bone cement.
The Maestro™ Carpal HemiArthroplasty is a three piece carpal component designed to articulate with the natural radial bone. The carpal component consists of 3 sub-components - a carpal head, a carpal plate and a capitate stem. The carpal head comes in 3 heights, standard, +2 and +4. This allows the surgeon to adjust for soft tissue laxity. Two lengths of carpal plates give the surgeon options of screw placement.
The provided text does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) summary for the Maestro™ Carpal HemiArthroplasty. It states:
- Non-Clinical Testing: "Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions." However, no specific acceptance criteria, performance metrics, or study details (like sample size, methodology, or results) are provided.
- Clinical Testing: The document explicitly states: "None provided."
Therefore, I cannot provide the requested table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert involvement, or comparative effectiveness. The information is simply not present in the provided text.
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050028
12
MAR 25 2005
BIOMET
510(k) Summary
Applicant/Sponsor: Biomet Manufacturing Corp.
Contact Person: Patricia Sandborn Beres Senior Requlatory Specialist
Proprietary Name: Maestro™ Carpal HemiArthroplasty
Partial Wrist Joint Common Name:
Classification Name: Prosthesis, Wrist Carpal Lunate (21 CFR 888.3750 and/or Prosthesis, Wrist, Carpal Scaphoid (21 CFR 888.3760)
The Maestro™ Carpal HemiArthroplasty requires removal of both the lunate and the scaphoid bones therefore it does not clearly fit one classification
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Swanson Titanium Carpal Scaphoid Implant (Wright Medical Technologies) - K864490 Swanson Titanium Carpal Lunate Implant (Wright Medical Technologies) -
Maestro™ Total Wrist System (Biomet Manufacturing Corp.) - K042032
Device Description: The Maestro™ Carpal HemiArthroplasty is a three piece carpal component designed to articulate with the natural radial bone. The carpal component consists of 3 sub-components - a carpal head, a carpal plate and a capitate stem. The carpal head comes in 3 heights, standard, +2 and +4. This allows the surgeon to adjust for soft tissue laxity. Two lengths of carpal plates give the surgeon options of screw placement.
MAILING ADDRESS SHIPPING ADDRESS 56 E. Bell Drive P.O. Box 587 Warsaw, IN 46581 0587 Warsaw, IN 46582 ()FFICE ドAX 1 574.267 6639 574.267.8137
133
E-MAIL biomet@biomet.com
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510(k) Summary Maestro™ Hemi-Wrist Page 2
lntended Use: The Maestro™ Carpal HemiArthroplasty is indicated for use as a replacement of wrist joints disabled by pain, deformity and/or limited motion caused by:
2/2
KIDS 30 7 3
-
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Revision where other devices or treatments have failed
-
- Scapholunate Advanced Collapse (SLAC) and other functional deformities
-
- Trauma, including fractures of the carpal bones
The device is intended to be implanted with bone cement.
Summary of Technologies: The overall design, materials, surface finishes and processing of the Maestro™ Carpal HemiArthroplasty are similar or identical to the predicate devices.
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions.
Clinical Testing: None provided
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corporation 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K050028
Trade/Device Name: Maestro™ Carpal HemiArthroplasty Regulation Numbers: 21 CFR 888.3750, 21 CFR 888.3760 Regulation Names: Wrist joint carpal lunate polymer prosthesis, Wrist joint carpal scaphoid polymer prosthesis Regulatory Class: II Product Codes: KWN, KWN, KWO Dated: January 5, 2005 Received: January 6, 2005
Dear Ms. Beres:
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. Patricia Sandborn Beres
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
the Hype Purdu
Miriam C. Provost, Ph.D.
C. Provost, Ph.D Miriam Acting 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
510(k) Number (if known):
Device Name: Maestro TM Carpal HemiArthroplasty
Indications For Use: The Maestro™ Carpal HemiArthroplasty is indicated for use as a replacement of wrist joints disabled by pain, deformity and/or limited motion caused by:
-
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Revision where other devices or treatments have failed
-
- Scapholunate Advanced Collapse (SLAC) and other functional deformities
-
- Trauma, including fractures of the carpal bones
The device is intended to be implanted with bone cement.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stupt Clurdes
Division of General, Restorative, and Neurological Devices
Page 1 of 1
5100 - Num
§ 888.3750 Wrist joint carpal lunate polymer prosthesis.
(a)
Identification. A wrist joint carpal lunate prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal lunate bone of the wrist.(b)
Classification. Class II.