(71 days)
Not Found
No
The document describes a mechanical implant for wrist replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a wrist joint replacement system, indicated for conditions like arthritis, trauma, and deformities, to replace disabled wrist joints and address pain, deformity, and limited motion. These are all therapeutic actions.
No
Explanation: The device is a total wrist replacement system, intended for surgical implantation to replace disabled wrist joints. It is a treatment device, not a diagnostic one as it does not gather or interpret data to identify a medical condition.
No
The device description clearly outlines physical components (radial component, carpal component, stems, plates, heads) made of materials intended for surgical implantation, indicating it is a hardware medical device.
Based on the provided information, the Maestro™ Total Wrist System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a replacement for wrist joints disabled by various conditions. This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the physical components of a prosthetic wrist joint designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such tests.
Therefore, the Maestro™ Total Wrist System falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Maestro™ Total Wrist System 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 distal radius and/or carpal bones
The device is intended to be implanted with bone cement.
Product codes
JWJ
Device Description
The Maestro™ Total Wrist System consists of a two piece radial component with a molded bearing and a three-piece carpal component. The radial component is composed of a Titanium sheet with a modular stem. The distal bodies come in three sizes and have a molded polyethylene bearing surface. The stem is modular, assembled in the operating room by a screw assembly. The carpal component is comprised of 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 plates and fixed plates. Modular screw plates and fixed plates connect the capitate stems to the plate and head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist joints, distal radius, carpal bones
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions.
Clinical Testing: None provided
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
OCT 7 - 2004
BIOMET
510(k) Summary
Applicant/Sponsor: Biomet Manufacturing Corp.
Patricia Sandborn Beres Contact Person: Senior Regulatory Specialist
Proprietary Name: Maestro™ Total Wrist
Total Wrist Joint Common Name:
Classification Name: Wrist joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3800)
Legally Marketed Devices To Which Substantial Equivalence !s Claimed:
y Marketed Devroos Ten (DePuy Orthopedics, Inc.) – K031203 Blax™ A.F. Wilst System (Bor ay Orthopsers) - K020554 & K030037
Device Description: The Maestro™ Total Wrist System consists of a two piece Device Description: The Macotro and a three-piece carpal component.
radial component with a molded bearing and a three-piece carparent. The radial component with a moided body with a modular stem. The The fadial component is composse of a ather sheet polyethylene bearing
distal bodies come in three sizes and have a molded polyethylone bearing distal bodies come in thice sized and have the operating room by a screw surface. The stem is modular, assemblou in the operation of the managements – a carpal head, assembly. The carpal component ochoice or to ead comes in 3 heights, standard,
a carpal plate and a capitate stem. The carpal head comes in 3 heights of a carpar plate and a capitale stom. This othpan road tissue laxity. Two lengths of
+2 and +4. This allows the surgeon to adjust for soft tissue laxiby the radiol stoma +2 and +4. This allows the surgeon to aujust for aujust for surement. Like the radial stems,
carpal plates give the surgeon options of screw plates and bood carpar plates grro the carge the capitate stems to the plate and head.
Intended Use: The Maestro™ Total Wrist System is indicated for use as a Intended USe. The MacStro - Tecal vince of the Cycle relieve and/or limited motion caused by:
- caused by.
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis
-
- Rheumatoid arthritis
- 2 / Rhoumatold artillions or treatments have failed
-
- Revision where other devices of treather functional deformities
- Scapholunate Advanced Collapse (SLAC) and other functional deformities
-
- Scapholunate Autorial ss of the distal radius and/or carpal bones
The device is intended to be implanted with bone cement.
| MAILING ADDRESS | P.O. Box 587 |
|---|---|
| SHIPPING ADDRESS | 56 E. Bell Drive |
| Warsaw, IN 46581 |
| OFFICE | 574.267.6639 |
|---|---|
| FAX | 574.267.8137 |
| biomet@biomet.com |
151
1
510(k) Summary Maestro™ Total Wrist Page 2
Summary of Technologies: The overall design, materials, surface finishes and
esses of Technologic The Wijat or similar or identical to the predicate Summary of Technologies. The overall design, materials,
processing of the Maestro™ Total Wrist are similar or identical to the predicate devices.
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to the noff-om under expected clinical conditions.
Clinical Testing: None provided
All trademarks are owned by Biomet, Inc .except for the following:
All trademarks are owners . Be . Online . Incorporated All trademarks are owned by orthopaedics, Incorporated Blax is a trademarks of Bor ay enimes Medical Incorporated.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is black and white.
OCT 7 - 2004
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: K042032
K042052
Trade/Device Name: Maestro™ Total Wrist System Regulation Number: 21 CFR 888.3800 Regulation Name: Wrist joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWJ Dated: July 27, 2004 Received: July 28, 2004
Dear Ms. Beres:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your becaon 310(t) presidentially equivalent (for the indications felerenced above and nave determined in a weet ed predicate devices marketed in interstate for use stated in the cherosure) to regally attend date of the Medical Device American be to commence provided in accordance with the provisions of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tournal, controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is blushined (soo a croyals. Existing major regulations affecting your device can may be subject to sater additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Teast be advised that I Dris assuates over device complies with other requirements of the Act that I DA has made a dolorimistered by other Federal agencies. You must of any I ederal studies and registanents, including, but not limited to: registration and listing (21 comply will an the Fee orequirements)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 - Patricia Sandborn Beres
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.
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely vours,
Sincerely yours,
Mark A. Millman
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
4
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Maestro™ Total Wrist System
Indications For Use: The Maestro™ Total Wrist System is indicated for use as a Indications For Use: The Maestly -- Total White Oyoline innited motion caused by:
replacement of wrist joints disabled by pain, deformity and/or limited motio placement of wrist Joints uisabled by pain, dolorhilly and the sumatic
- arthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Theumatold antinatore articles or treatments have failed
-
- Revision where other devices of transmission in the functional deformities
- Scapholunate Advanced Collapse (SLAC) and other carpal bones
-
- Scapholunate Auvanced Collapse (SEAS)
- Trauma, including fractures of the distal radius and/or carpal bones
The device is intended to be implanted with bone cement.
× Prescription Use (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)
for (Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K042032 Page 1 of