(66 days)
Distal Volar Fracture Repair System
Not Found
No
The description focuses on the physical components (plates, screws, pins, k-wires) and manual surgical instruments. There is no mention of software, algorithms, or any technology that would suggest AI/ML is involved. The performance studies are based on material standards and equivalence testing, not algorithmic performance.
No
The device is described as an internal fixation system for bones, which is a structural support device, not a therapeutic device. It fixes fractures but does not treat a disease or condition itself.
No
The device description clearly states its purpose as "stabilization and fixation of small bone fragments" and details the components like plates, screws, and pins used for internal fixation, which are therapeutic actions, not diagnostic.
No
The device description explicitly states it is comprised of titanium plates, screws, pins, k-wires, and manual surgical instruments, which are all 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. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The provided information clearly describes a system of plates, screws, pins, and instruments used for the internal fixation and stabilization of bone fragments within the body. This is a surgical implant, not a diagnostic test performed on a specimen.
The device's function is to physically support and stabilize bones, which is a therapeutic intervention, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Fragment Plate System is intended for essentially non load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.
Product codes
KTT
Device Description
The Fragment Plate System is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. The set also includes screws, pins, and k-wires. The screws and pins are have a center drive head and are 2.5 mm in diameter. The plates will include "Y," straight, right, and left configurations. Manual surgical instruments are supplied with the system to facilitate implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.
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
The Hand Innovations, Inc. Fragment Plate Systems comply with the following standards, practices, and guidances:
- ASTM F366 82 (Reapproved 2000), Standard Specification for Fixation . Pins and Wires
- ASTM F 136 96, Standard Specification for Wrought Titanium-6 Alu-. minum-4 Vanadium ELI (Extra Low Interstitial) Alloy (R56401) for Surgical Implant Applications.
The Hand Innovations, Inc. Fragment Plate System is substantially equivalent to Distal Volar Fracture Repair System that is legally marketed and distributed by Hand Innovations, Inc. This has been demonstrated through a 13-point technological comparison of features and bench testing.
The implantable and tissue contact materials used to fabricate the Fragment Plate System and Instruments have a long history of safe usage in medical devices. Since the Hand Innovations, Inc. Fragment Plate Systems meet the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device. The Fragment Plate System will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Distal Volar Fracture Repair System
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
Summary of Safety and Effectiveness
for the
Fragment Plate System
submitted by
Hand Innovations, Inc.
8905 SW 87 Avenue
Miami, FL 33176-2227
Phone: 1 (800)-800-8188
K041081
page 1 of 2
JUL 01 2004
| Contact Person: | Al Weisenborn |
|---|---|
| Device Trade Name: | Fragment Plate System |
| Common Names: | Fragment Plates |
| Screws, pins, and k-wires | |
| Classification Names: | Plate, Fixation, Bone per 21 CFR § 888.3030 |
| Smooth or threaded metallic bone fixation fastener per 21 CFR § 888.3040 |
Identification of a Legally Marketed Predicate Device
The Hand Innovations, Inc. Fragment Plate System is substantially equivalent to Distal Volar Fracture Repair System that is legally marketed and distributed by Hand Innovations, Inc.
Device Description
The Fragment Plate System is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. The set also includes screws, pins, and k-wires. The screws and pins are have a center drive head and are 2.5 mm in diameter. The plates will include "Y," straight, right, and left configurations. Manual surgical instruments are supplied with the system to facilitate implantation.
Intended Use
The Fragment Plate System is intended for essentially non load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.
Summary of Technological Characteristics
A 13-point comparison of technological characteristics of the Hand Innovations, Inc. Fragment Plate System and the predicate device was performed. The devices were found to be substantially equivalent.
1
Summary of Performance Data
The Hand Innovations, Inc. Fragment Plate Systems comply with the following standards, practices, and guidances:
- ASTM F366 82 (Reapproved 2000), Standard Specification for Fixation . Pins and Wires
- ASTM F 136 96, Standard Specification for Wrought Titanium-6 Alu-. minum-4 Vanadium ELI (Extra Low Interstitial) Alloy (R56401) for Surgical Implant Applications.
The Hand Innovations, Inc. Fragment Plate System is substantially equivalent to Distal Volar Fracture Repair System that is legally marketed and distributed by Hand Innovations, Inc. This has been demonstrated through a 13-point technological comparison of features and bench testing.
The implantable and tissue contact materials used to fabricate the Fragment Plate System and Instruments have a long history of safe usage in medical devices. Since the Hand Innovations, Inc. Fragment Plate Systems meet the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device. The Fragment Plate System will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 0 1 2004
Al Weisenborn Hand Innovations, Inc. 8905 SW 87 Avenue Miami, Florida 33176-2227
Re: K041081
Trade/Device Name: Fragment Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: April 23, 2004 Received: April 27, 2007
Dear Weisenborn:
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 -
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 yours,
Miriam C. Provost
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
Page 1 of 1
KA1081 510(k) Number (if known):
Device Name: Fragment Plate System
Indications for Use:
The Fragment Plate System is intended for essentially non load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) mirian C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Prescription Use_ X (Per 21 CFR 801.109)
510(k) Number OR K 04/08/ Over-The-Counter Use
(Optional Format 1-2-96)