(67 days)
Avanta SCS/V Distal Radius Plate, Hand Innovations DVR Plate, Synthes Locking Distal Radius System 2.4
Not Found
No
The summary describes a mechanical implant system for fracture fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is a titanium implant system designed for fracture fixation and repair of distal radius fractures, which are therapeutic interventions.
No
The device is described as an "implant fracture fixation system" used for the treatment of distal radius fractures, not for diagnosing conditions.
No
The device description clearly states it is a titanium implant fracture fixation system including plates and screws, which are physical 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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a titanium implant fracture fixation system (a plate and screws) used to surgically repair broken bones in the wrist. This is a physical implant used within the body, not a device that analyzes samples outside the body.
- Intended Use: The intended use is to fix fractures and malunions of the distal radius, which is a surgical procedure.
Therefore, based on the description and intended use, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The I.T.S. Volar Radius Plate with Angular Stability is a titanium implant fracture fixation system for distal radius fractures of the wrist.
Indications for Use include comminuted extra and intra-articular distal radius fractures, failed original fracture fixation, osteotomy and repair of a distal radius malunion, and comminuted volar shearing fractures
The I.T.S. Volar Radius Plate system provides immediate stability, rapid recovery, and prompt wrist functionality.
Product codes
HRS
Device Description
The I.T.S. Volar Radius Plate with Angular Stability provides various width 4 and 6 hole standard plates, various width 8, 10, and 12 hole long plates, various length stabilization screws, and various length cortical fixation screws. The volar radius plates are made from CP Titanium according to ASTM F 67-00 and the screws are made from 6-4 Alloyed Titanium according to ASTM F 136-98.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Avanta SCS/V Distal Radius Plate, Hand Innovations DVR Plate, Synthes Locking Distal Radius System 2.4
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary of Safety and Effectiveness Section XII:
| FEB - 6 2004 | SAFE MEDICAL DEVICES ACT OF 1990
510(k) Summary |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NAME OF FIRM: | I.T.S. Implantat-Technologie-Systeme GmbH.
Autal 28.
Lassnitzhoche A-8301
AUSTRIA |
| 510(k) FIRM CONTACT: | Al Lippincott
Engineering Consulting Services, Inc.
3150 E. 200th St.
Prior Lake, MN 55372 |
| TRADE NAME: | Volar Radius Plate with Angular Stability |
| COMMON NAME: | Fracture Fixation Plating system for fracture fixation of the end of
long bones |
| CLASSIFICATION: | Single/multiple component metallic bone fixation appliances and
accessories (see 21 CRF, Sec. 888.3030). |
| DEVICE PRODUCT CODE: HRS | |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | Avanta SCS/V Distal Radius Plate - Volar
Hand Innovations DVR Plate
Synthes Locking Distal Radius System 2.4 |
| DEVICE DESCRIPTION: | The I.T.S. Volar Radius Plate with Angular Stability provides
various width 4 and 6 hole standard plates, various width 8, 10,
and 12 hole long plates, various length stabilization screws, and
various length cortical fixation screws. The volar radius plates are
made from CP Titanium according to ASTM F 67-00 and the
screws are made from 6-4 Alloyed Titanium according to ASTM F
136-98. |
| INTENDED USE: | The I.T.S. Volar Radius Plate is used to stabilize distal radius
fractures in the wrist with an accurate retention of articular fracture
elements. |
| BASIS OF SUBSTANTIAL
EQUIVALENCY: | The I.T.S. Volar Radius Plate is substantially equivalent to the
Avanta, Hand Innovations, and Synthes fracture plating systems |
| SUMMARY OF SAFETY
AND EFFECTIVENESS: | The I.T.S. Volar Radius Plate system is shown to be safe and
effective for use in fracture fixation of the distal radius in the wrist. |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
FEB - 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
I.T.S. Implantat-Technologie-Systeme GMBH Al Lippincott c/o Engineering Consulting Services, Inc. 3150 East 2000 Street Prior Lake, Minnesota 55372
Re: K033756
Trade/Device Name: Volar Radius Plate with Angular Stability Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: November 24, 2003 Received: December 1, 2003
Dear Mr. Lippincott:
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 docs 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 -- Mr. Al Lippincott
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 you
Mark A. Mulkeen
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
3
Image /page/3/Picture/0 description: The image shows a sequence of characters and symbols. The characters appear to be "i", "T", and "S", each enclosed in a rectangular box. Below each character is a solid black circle. To the right of the "S" is a right-pointing arrow, also enclosed in a rectangular box.
Image /page/3/Picture/1 description: The image contains two distinct elements. On the left, there is a bold, stylized letter 'S' with a curved design. To the right of the 'S', there is a triangular shape filled with a textured, grainy pattern, creating a contrast between the smooth letter and the rough triangle.
Spectromed
Geschäftsführer: Herbert Seinsteiner & Dr Eva Rapter Mer
8301 Laßnitzhohe/Grat, Austria Antal 28
Spectromed GmbH lef=043 Ho241 21 0 - 1ax=43 316 211 21 30 l mail verkant-spectromed net IN 34940 h. DVR 0747473
1.T.S. Implantat · Technologie-Systeme GmbH lel .: . 43 316 211 21 0 Tax: +43 316 211 21 20 www.ts implant.com - [ mail:its@its amplant.com I N 16396ab - DVR 0934704
510(k) NUMBER: K033756
DEVICE NAME: Volar Radius Plate
INDICATIONS FOR USE:
The I.T.S. Volar Radius Plate with Angular Stability is a titanium implant fracture fixation system for distal radius fractures of the wrist.
Indications for Use include comminuted extra and intra-articular distal radius fractures, failed original fracture fixation, osteotomy and repair of a distal radius malunion, and comminuted volar shearing fractures
The I.T.S. Volar Radius Plate system provides immediate stability, rapid recovery, and prompt wrist functionality.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
001 FUB B
OR
Over-The-Counter-Use
(Optional Format)
for Mark A. Melber