(55 days)
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Not Found
No
The summary describes a bioresorbable screw and its mechanical properties, with no mention of AI or ML technology.
Yes
The device is indicated for correction of hallux valgus (bunion) and repair of metacarpal and phalangeal fusion and fractures, which are therapeutic procedures.
No
The ReUnite™ Screws are described as a surgical implant used for correcting hallux valgus and repairing metacarpal and phalangeal fusions and fractures, not for diagnosing conditions.
No
The device description clearly states the device is a physical screw made of bioresorbable polymer, not software.
Based on the provided information, the ReUnite™ Screws are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- ReUnite™ Screws Function: The description clearly states that the ReUnite™ Screws are surgical implants made of a bioresorbable polymer. They are used in vivo (within the body) for the mechanical fixation of bones during surgical procedures like hallux valgus correction and fracture repair.
- Lack of IVD Characteristics: The description does not mention any use of specimens from the body, laboratory testing, or diagnostic purposes. The performance studies focus on mechanical strength and resorption time in vivo.
Therefore, the ReUnite™ Screws are a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The ReUnite™ Bone Screws are indicated for use in the presence of appropriate immobilization in the following procedures:
- correction of hallux valgus (bunion)
- repair of metacarpal and phalangeal fusion and fracture
Product codes
87 HWC, MAI
Device Description
The ReUnite™ Screws are made of bioresorbable and biocompatible polymer that have been used in surgical procedures for a number of years. LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLLA/PGA) acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The effectiveness of the resorbable screws was determined by mechanical testing. These screws are as strong or stronger than the LactoSorb® Bone Pin. The device completely resorbs in approximately 12 months IN VIVO eliminating the need for long-term removal.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the text "P - 1 1000". The text is in a simple, sans-serif font. The text is slightly blurred, but still legible. The background is white.
Summary of Safety and Effectiveness
| Submitter: | Biomet, Inc.
P.O. Box 587
Airport Industrial Park
Warsaw, Indiana 46581-0587 |
|-----------------|---------------------------------------------------------------------------------------|
| Contact Person: | Michelle L. McKinley |
| Product Code: | 87 HWC |
| Device Name: | ReUnite™ Screws |
The ReUnite™ Bone Screws are indicated for use in the presence of appropriate immobilization in the following procedures:
-
- correction of hallux valgus (bunion)
-
- repair of metacarpal and phalangeal fusion and fracture
The ReUnite™ Screws are made of bioresorbable and biocompatible polymer that have been used in surgical procedures for a number of years. LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLLA/PGA) acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissues.
The effectiveness of the resorbable screws was determined by mechanical testing. These screws are as strong or stronger than the LactoSorb® Bone Pin. The device completely resorbs in approximately 12 months IN VIVO eliminating the need for long-term removal.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 1 1999
Ms. Michelle L. McKinley Regulatory Specialist Biomet Incorporated P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K992301
Trade Name: ReUniteTM Screw Regulatory Class: II Product Code: HWC and MAI Dated: July 6, 1999 Received: July 8,1999
Dear Ms. McKinley:
ﺎﺳﺘ
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 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 (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 (OS) 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 – Ms. Michelle L. McKinley
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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
210(K) NUMBER (IF KNOWN): KJA 230 /
DEVICE NAME: ReUnite™ Screw
INDICATIONS FOR USE:
The ReUnite™ Screws are indicated for use in the presence of appropriate immobilization in the following procedures:
-
- correction of hallux valgus (bunion)
-
- repair of metacarpal and phalangeal fusion and fractures
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
ﺳ
OR
Over-the-Counter Use (Optional Format 1-2-96)
hoadey
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K99230
.