K Number
K080426
Device Name
MAESTRO WRIST FRACTURE IMPLANT
Date Cleared
2008-07-29

(160 days)

Product Code
Regulation Number
888.3800
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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: 1) Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis. 2) Rheumatoid arthritis. 3) Revision where other devices or treatments have failed. 4) Scapholunate Advanced Collapse (SLAC) and other functional deformities. 5) Trauma, including fractures of the distal radius and/or carpal bones. The radial and carpal components are intended to be implanted with bone cement.
Device Description
The Maestro™ Wrist Fracture Replacement System consists of a two piece radial component and a molded carpal bearing component for total wrist replacement. The radial component is composed of a distal body with a modular stem. The distal bodies have a highly polished bearing surface located anatomically. The Maestro™ Tapered Carpal Component is composed of three subcomponents - a carpal head, a carpal plate and a capitate stem. The carpal head is composed of polyethylene molded on to a metallic base. The carpal plate has a male taper which mates with a female taper in the carpal head. The plate features threaded screw holes that mate with the heads of spherical locking screws. Screws are available with both fixed and variable heads. The variable screws allow the surgeon to angle the screws upon insertion while still locking the screws to the plate. The capitate stem then screws into internal threads on the reverse side of the taper on the carpal plate to complete the implant.
More Information

Not Found

No
The summary describes a mechanical implant for wrist replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.

Yes
The device is a wrist joint replacement system intended to alleviate pain, deformity, and limited motion caused by various conditions affecting the wrist, which are therapeutic goals.

No

This device is a total wrist replacement system, indicated for replacing damaged wrist joints. Its purpose is to treat pain, deformity, and limited motion, rather than to diagnose conditions.

No

The device description clearly outlines physical components (radial component, carpal bearing component, carpal head, carpal plate, capitate stem, screws) made of materials like polyethylene and metal, indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the Maestro™ Total Wrist System is a replacement for wrist joints. This is a surgical implant used in vivo (within the body) to treat a physical condition.
  • Device Description: The description details the components of a surgical implant (radial component, carpal bearing component, screws, etc.) designed to be surgically implanted.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.

IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.

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 1) arthritis and avascular necrosis.
    1. Rheumatoid arthritis.
  • Revision where other devices or treatments have failed. 3)
  • Scapholunate Advanced Collapse (SLAC) and other functional deformities. 4)
  • Trauma, including fractures of the distal radius and/or carpal bones. 5)

The radial and carpal components are intended to be implanted with bone cement.

Product codes (comma separated list FDA assigned to the subject device)

JWJ

Device Description

The Maestro™ Wrist Fracture Replacement System consists of a two piece radial component and a molded carpal bearing component for total wrist replacement. The radial component is composed of a distal body with a modular stem. The distal bodies have a highly polished bearing surface located anatomically. The Maestro™ Tapered Carpal Component is composed of three subcomponents - a carpal head, a carpal plate and a capitate stem. The carpal head is composed of polyethylene molded on to a metallic base. The carpal plate has a male taper which mates with a female taper in the carpal head. The plate features threaded screw holes that mate with the heads of spherical locking screws. Screws are available with both fixed and variable heads. The variable screws allow the surgeon to angle the screws upon insertion while still locking the screws to the plate. The capitate stem then screws into internal threads on the reverse side of the taper on the carpal plate to complete the implant.

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: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K042032, K050028

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

§ 888.3800 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

K080426 pg lot2

Image /page/0/Picture/1 description: The image shows the logo for Biomet Orthopedics, Inc. The logo consists of the word "BIOMET" in a stylized, blocky font, with a registered trademark symbol to the right of the word. Below the word "BIOMET" is the phrase "ORTHOPEDICS, INC." in a smaller, simpler font. The logo is black and white.

510(k) Summary

Preparation Date: July 7, 2008

Applicant/Sponsor:Biomet Manufacturing Corp. 56 East Bell Drive Warsaw, IN 46582

JUL 2 9 2008

Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist

Proprietary Name: Maestro™ Wrist Fracture Implant

Common Name: Total wrist replacement device

Classification Name:

Wrist joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3800)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

  • · Maestro™ Total Wrist System, 510(k) K042032
  • · Maestro™ Carpal HemiArthroplasty, 510(k) K050028

Device Description:

The Maestro™ Wrist Fracture Replacement System consists of a two piece radial component and a molded carpal bearing component for total wrist replacement. The radial component is composed of a distal body with a modular stem. The distal bodies have a highly polished bearing surface located anatomically. The Maestro™ Tapered Carpal Component is composed of three subcomponents - a carpal head, a carpal plate and a capitate stem. The carpal head is composed of polyethylene molded on to a metallic base. The carpal plate has a male taper which mates with a female taper in the carpal head. The plate features threaded screw holes that mate with the heads of spherical locking screws. Screws are available with both fixed and variable heads. The variable screws allow the surgeon to angle the screws upon insertion while still locking the screws to the plate. The capitate stem then screws into internal threads on the reverse side of the taper on the carpal plate to complete the implant.

Mailing Address:

P.O. Box 587
Warsaw, IN 46581-0587
Toll Free: 800.348.9500
Office: 574.267.6639
Main Fax: 574.267.8137
www.biomet.com

Shipping Address:
56 East Bell Drive
Warsaw, IN 46582

1

K080426 pg 2 of 2

Intended 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 1) arthritis and avascular necrosis.
    1. Rheumatoid arthritis.
  • Revision where other devices or treatments have failed. 3)
  • Scapholunate Advanced Collapse (SLAC) and other functional deformities. 4)
  • Trauma, including fractures of the distal radius and/or carpal bones. 5)

The radial and carpal components are intended to be implanted with bone cement.

Summary of Technologies: The Maestro™ Wrist Fracture Implant has similar technologies as the predicate device.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corp. % Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 East Bell Drive Warsaw, IN 46582

JUL 2 9 2008

Re: K080426 Trade/Device Name: Maestro Wrist Fracture Implant Regulation Number: 21 CFR 888.3800 Regulation Name: Wrist joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWJ Dated: July 21, 2008 Received: July 22, 2008

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.

3

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Millican

Mark N. Melkerson 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): ___K080426

Device Name: Maestro™ Wrist Fracture Implant

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 1) arthritis and avascular necrosis.
  • Rheumatoid arthritis. 2)
  • Revision where other devices or treatments have failed. 3)
  • Scapholunate Advanced Collapse (SLAC) and other functional deformities. 4)
  • Trauma, including fractures of the distal radius and/or carpal bones. 5)

The radial and carpal components are intended to be implanted with bone cement.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (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)
--------------------------------------------------------

Mark A. McHenas(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K080426