(57 days)
Not Found
Not Found
No
The summary describes a mechanical implant (plates and screws) for wrist fusion and fracture fixation. There is no mention of software, algorithms, or any technology that would suggest AI/ML is involved. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is intended for wrist arthrodesis and fractures of other small bones, as well as addressing conditions like post-traumatic arthritis, rheumatoid deformities, and severe wrist pain, all of which are therapeutic interventions.
No
The device is a wrist fusion plate intended for surgical fixation of the wrist and small bones, not for diagnosing conditions. Its description focuses on its material and design for orthopedic repair.
No
The device description clearly states it is a physical plate made of Titanium or Stainless Steel, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Synthes LCP Wrist Fusion Plates are implants used for surgical procedures (wrist arthrodesis and fracture fixation). They are physically placed within the body to stabilize bones.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic information derived from such tests.
This device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Synthes (USA) LCP Wrist Fusion Plates are intended for wrist arthrodesis and fractures of other small bones. Specific indications include post-traumatic arthritis of the joints of the wrist; rheumatoid wrist deformities requiring restoration; complex carpal instability; post-septic arthritis of the wrist; severe unremitting wrist pain related to motion; brachial plexus nerve palsies; tumor resection; and spastic deformities.
Product codes
HRS
Device Description
The Synthes LCP Wrist Fusion Plates are pre-contoured with a limited contact design utilizing a short bend with a 3.3 mm thickness and a width of 11 mm. The plate uses a total of 10 combination holes which utilizes 2.7 mm and 3.5 mm cortex and locking screws. The plates are available in Titanium and Stainless Steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist, small 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes Straight Wrist Fusion Plate, 170 mm
Reference Device(s)
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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/0 description: The image shows the logo for SYNTHES. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. There is a registered trademark symbol after the word SYNTHES. A horizontal line is present below the word.
OCT 2 7 2004
3.0 510(k) Summary
| Sponsor: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes (USA) LCP Wrist Fusion Plates |
| Classification: | Class II, 21 CFR §888.3030
Single/multiple component metallic bone fixation appliances and
accessories |
| Predicate Device: | Synthes Straight Wrist Fusion Plate, 170 mm |
| Device Description: | The Synthes LCP Wrist Fusion Plates are pre-contoured with a
limited contact design utilizing a short bend with a 3.3 mm
thickness and a width of 11 mm. The plate uses a total of 10
combination holes which utilizes 2.7 mm and 3.5 mm cortex and
locking screws. The plates are available in Titanium and Stainless
Steel. |
| Intended Use: | Synthes (USA) LCP Wrist Fusion Plates are intended for wrist
arthrodesis and fractures of other small bones. Specific indications
include post-traumatic arthritis of the joints of the wrist; rheumatoid
wrist deformities requiring restoration; complex carpal instability;
post-septic arthritis of the wrist; severe unremitting wrist pain related
to motion; brachial plexus nerve palsies; tumor resection; and spastic
deformities. |
| Substantial
Equivalence: | Documentation is provided which demonstrates that Synthes LCP
Wrist Fusion Plates are substantially equivalent to other legally
marketed Synthes devices. |
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, connected and flowing together in a wave-like form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 2004
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K042355
Trade/Device Name: Synthes (USA) LCP Wrist Fusion Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/ multiple component metallic bone fixation appliances and accessories. Regulatory Class: II Product Code: HRS Dated: August 30, 2004 Received: August 31, 2004
Dear Ms. Musgnung:
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.
2
Page 2 - Ms. Sheri L. Musgnung
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/dsma/dsmamain.html
Sincerely yours.
Marl A. Millers
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
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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line runs underneath the word "SYNTHES" and the logo. The logo appears to be a registered trademark.
Indications for Use
510(k) Number (if known):
Device Name: | Synthes (USA) LCP Wrist Fusion Plates |
---|---|
Indications: | Synthes (USA) LCP Wrist Fusion Plates are intended for wrist |
arthrodesis and fractures of other small bones. Specific | |
indications include post-traumatic arthritis of the joints of the | |
wrist; rheumatoid wrist deformities requiring restoration; | |
complex carpal instability; post-septic arthritis of the wrist; | |
severe unremitting wrist pain related to motion; brachial plexus | |
nerve palsies; tumor resection; and spastic deformities. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 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)
l Mal n Mill
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
K042335 510(k) Number_________________________________________________________________________________________________________________________________________________________________
090004