(70 days)
Not Found
No
The device description focuses on mechanical components for fracture fixation and mentions a modification to the sterilization cycle. There is no mention of AI or ML in the provided text.
Yes
The device is intended for the fixation of fractures and osteotomies, which are medical treatments for injuries or conditions.
No
Explanation: The device is a Distal Radius Fracture Repair Kit, which is used for the "fixation of fractures and osteotomies involving the distal radius." This description indicates that the device is a therapeutic or surgical tool designed to repair physical damage, not to diagnose a condition.
No
The device description explicitly details hardware components such as plates, screws, pegs, nails, and surgical tools made of titanium and stainless steel. The 510(k) is for a modification to the sterilization cycle of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the fixation of fractures and osteotomies involving the distal radius." This describes a surgical procedure performed directly on a patient's bone, not a test performed on a sample taken from the body.
- Device Description: The device consists of plates, screws, pegs, and instruments used for bone repair. These are all surgical implants and tools, not reagents, instruments, or software used to examine specimens from the human body.
- No mention of biological samples: The description does not mention the collection, analysis, or examination of any biological samples (blood, urine, tissue, etc.).
- No mention of diagnostic information: The device is used for treatment (fixation of fractures), not for providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Distal Radius Fracture Repair Kit is intended for the fixation of fractures and osteotomies involving the distal radius.
The Distal Radius Fracture Repair System is intended for the fixation of fractures and osteotomies involving the distal radius.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Distal Radius Fracture Repair System was previously cleared under 510(k) No. K023007. The system consists of a volar stabilization plate, bone screws, fixation pegs, dorsal intrafocal nail-plate, three fixed angle bone pegs and two locking screws. This 510(k) is being submitted as a modification to the original 510(k) No. K023007 to update and standardize the sterilization cycle. A copy of the clearance letter is enclosed with this submission.
The Distal Volar Radius Plate (DVR) consists of a stabilization plate, bone screws, and fixation pegs. The 3.5 mm screws are used to affix the proximal segment of the plate to the diaphysis. Pegs or screws are used for the distal bone fragment(s).
The Distal Dorsal Nail-Plate (DNP) is a bone stabilization device consisting of an intrafocal nail-plate to which three-fixed angle bone pegs and two locking screws are attached. It has a narrow distal plate-like section that lies on the surface of the distal fragment and a proximal nail-like section that is introduced into the diaphysis of the radius through the fracture site. Fixed angle pegs are used to fix the distal fragment(s) to the plate section and locking screws are used to lock the proximal fragment inside the radial shaft.
Other components used in the implantation process are identified as the DNP Jig Set of Stainless Steel SST 17-4. These items consist of the DNP Jig (left or right), drill guide, screw jig and screw guide.
A standard awl, which is a manual tool, used to increase the size of a hole or tunnel by scraping in rotation is a standard catalog item manufactured by from K-Medic under catalog no. KM-48-336.
The components of this system will be packaged together and will also be available individually. The materials used for the various components in Distal Radius Fracture Repair System include the following:
| Name | Part No. | Material Composition |
|---|---|---|
| Volar Plate, Right | Titanium TI-6AL-4V ELI | |
| Volar Plate, Left | Titanium TI-6AL-4V ELI | |
| Dorsal Nail Plate Right | DRW-067 | Titanium TI-6AL-4V ELI |
| Dorsal Nail Plate Left | DRW-054 | Titanium TI-6AL-4VELI |
| Peg Volar Plate | ||
| (14,16,18,20,22,24,26,28mm) 010, DRW-055/DRW-056 (Table DRW-20) | DRW-005/056 | Titanium TI-6AL-4V ELI |
| Threaded peg 2.5 mm | ||
| (14,16,18,20,22,24,26,28mm) 033, DRW-057/DRW-058 (Table DRW-026) | DRW-028/033 | Titanium TI-6AL-4V ELI |
| Screw, 2.5mm (14,16,18,20,22,24,26,28mm) | DRW-034/039, DRW-059/DRW-060 | Titanium TI-6AL-4V ELI |
| Peg Driver Assembly | DRW-016 | Stainless Steel 440C |
| Drill Guide | DRW-017 | Stainless Steel 440C |
| DNP Jig, Left | DRW-062 | Stainless Steel SST-17-4 |
| DNP Jig, Right | DRW-063 | Stainless Steel SST-17-4 |
| DNP Screw Jig | DRW-064 | Stainless Steel SST-17-4 |
| DNP Screw Guide | DRW-065 | Stainless Steel SST-17-4 |
| DNP Drill Guide | DRW-066 | Stainless Steel SST-17-4 |
| Depth Gauge | Supplied by K-Medic | Off the shelf catalog item. |
| Drill, 2.0mm | Supplied by Microaire | Off the shelf catalog item. |
| Awl | Supplied by K-Medic | Off the shelf catalog item. |
| Name | Part No. | Material Composition |
| Screw Holding Sleeve | Supplied by K-Medic | Off the shelf catalog item. |
| Drill, 2.5 mm | Supplied by Microaire | Off the shelf catalog item. |
| Drill, 1.8 mm | Supplied by Microaire | Off the shelf catalog item. |
| Hex Driver | Supplied by K-Medic | Off the shelf catalog item. |
| Plate Bender | Supplied by K-Medic | Off the shelf catalog item. |
| Tissue Guide | Supplied by K-Medic | Off the shelf catalog item. |
| Screw Rack | DRW-018 | Not a device. |
| Sterilization Tray | DRW-019 | Not a device. |
The components within this system will be provided as non-sterile for steam sterilization by health care professionals prior to use. Instructions for sterilizations are contained in the package insert. The kit components will also be available separately provided as non-sterile for steam sterilization by the healthcare professional.
The system is packaged in a high tempered plastic sterilization tray. The tray is provided with inserts to retain the components. The tray is placed in a polymeric bag and placed into a shipping carton. All components sold separately are packaged in polymeric pouches.
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
health care professionals
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): 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.
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
§ 888.3030 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
K030198
page 1 of 4
1. Manufacturer and Contact Information:
| Manufacturer
& U. S. Distributor | Hand Innovations, Inc.
8905 S. W. 87th Avenue
Miami, FL 33175-2227 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Richard D. Bliss, Jr.
Quality Systems Engineering
510 Stonemont Drive
Weston, FL 33326
Telephone: (954) 385-1690
Fax: (954) 385-1256 |
2. Device Classification Name:
The Orthopedic Devices Panel has classified the single/multiple component metallic bone fixation appliances and accessories as Class II. Reference 21 CFR 888.3030.
3. Intended Use:
The Distal Radius Fracture Repair Kit is intended for the fixation of fractures and osteotomies involving the distal radius.
4. Device Description and Characteristics
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) 1990 and the FDA Modernization Act of 1997 (FDAMA).
The Distal Radius Fracture Repair System was previously cleared under 510(k) No. K023007. The system consists of a volar stabilization plate, bone screws, fixation pegs, dorsal intrafocal nail-plate, three fixed angle bone pegs and two locking screws. This 510(k) is being submitted as a modification to the original 510(k) No. K023007 to update and standardize the sterilization cycle. A copy of the clearance letter is enclosed with this submission.
The Distal Volar Radius Plate (DVR) consists of a stabilization plate, bone screws, and fixation pegs. The 3.5 mm screws are used to affix the proximal segment of the plate to the diaphysis. Pegs or screws are used for the distal bone fragment(s).
The Distal Dorsal Nail-Plate (DNP) is a bone stabilization device consisting of an intrafocal nail-plate to which three-fixed angle bone pegs and two locking screws are attached. It has a narrow distal plate-like section that lies on the surface of the distal fragment and a proximal nail-like section that is introduced into the diaphysis of the radius through the fracture site. Fixed angle pegs are used to fix the distal fragment(s) to the plate section and locking screws are used to lock the proximal fragment inside the radial shaft.
1
K030198
page 2 of 4
Other components used in the implantation process are identified as the DNP Jig Set of Stainless Steel SST 17-4. These items consist of the DNP Jig (left or right), drill guide, screw jig and screw guide.
A standard awl, which is a manual tool, used to increase the size of a hole or tunnel by scraping in rotation is a standard catalog item manufactured by from K-Medic under catalog no. KM-48-336.
The components of this system will be packaged together and will also be available individually. The materials used for the various components in Distal Radius Fracture Repair System include the following:
| Name | Part No. | Material Composition |
|---|---|---|
| Volar Plate, Right | Titanium TI-6AL-4V ELI | |
| Volar Plate, Left | Titanium TI-6AL-4V ELI | |
| Dorsal Nail Plate Right | DRW-067 | Titanium TI-6AL-4V ELI |
| Dorsal Nail Plate Left | DRW-054 | Titanium TI-6AL-4VELI |
| Peg Volar Plate | ||
| (14,16,18,20,22,24,26,28mm) 010, DRW-055/DRW-056 (Table DRW-20) | DRW-005/056 | Titanium TI-6AL-4V ELI |
| Threaded peg 2.5 mm | ||
| (14,16,18,20,22,24,26,28mm) 033, DRW-057/DRW-058 (Table DRW-026) | DRW-028/033 | Titanium TI-6AL-4V ELI |
| Screw, 2.5mm (14,16,18,20,22,24,26,28mm) | DRW-034/039, DRW-059/DRW-060 | Titanium TI-6AL-4V ELI |
| Peg Driver Assembly | DRW-016 | Stainless Steel 440C |
| Drill Guide | DRW-017 | Stainless Steel 440C |
| DNP Jig, Left | DRW-062 | Stainless Steel SST-17-4 |
| DNP Jig, Right | DRW-063 | Stainless Steel SST-17-4 |
| DNP Screw Jig | DRW-064 | Stainless Steel SST-17-4 |
| DNP Screw Guide | DRW-065 | Stainless Steel SST-17-4 |
| DNP Drill Guide | DRW-066 | Stainless Steel SST-17-4 |
| Depth Gauge | Supplied by K-Medic | Off the shelf catalog item. |
| Drill, 2.0mm | Supplied by Microaire | Off the shelf catalog item. |
| Awl | Supplied by K-Medic | Off the shelf catalog item. |
| Name | Part No. | Material Composition |
| Screw Holding Sleeve | Supplied by K-Medic | Off the shelf catalog item. |
| Drill, 2.5 mm | Supplied by Microaire | Off the shelf catalog item. |
| Drill, 1.8 mm | Supplied by Microaire | Off the shelf catalog item. |
| Hex Driver | Supplied by K-Medic | Off the shelf catalog item. |
| Plate Bender | Supplied by K-Medic | Off the shelf catalog item. |
| Tissue Guide | Supplied by K-Medic | Off the shelf catalog item. |
| Screw Rack | DRW-018 | Not a device. |
| Sterilization Tray | DRW-019 | Not a device. |
2
Kozol98
The components within this system will be provided as non-sterile for steam sterilization by health care professionals prior to use. Instructions for sterilizations are contained in the package insert. The kit components will also be available separately provided as non-sterile for steam sterilization by the healthcare professional.
The system is packaged in a high tempered plastic sterilization tray. The tray is provided with inserts to retain the components. The tray is placed in a polymeric bag and placed into a shipping carton. All components sold separately are packaged in polymeric pouches.
See Modification of Device Section for the Kit Manufacturer's Certification Statement containing a complete listing of all components.
5. Substantial Equivalence
Hand Innovations Inc. considers the modifications to this Distal Radius Fracture Repair System to be substantially equivalent to the Distal Radius Fracture Repair System. 510(k) No. K023007 that cleared FDA on December 5, 2002. with regard to the intended use, materials, biocompatibility and overall performance characteristics. The current labeling for the Distal Radius Fracture Repair System has been revised to reflect the change in the sterilization cycle.
3
030198
page 4 of 4
Summary of Substantial Equivalence
| Feature | Distal Radius Fracture
Repair Kit | Distal Radius Fracture
Repair Kit
(Predicate Device) |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hand Innovations, Inc. | Hand Innovations, Inc. |
| Packaging | Tempered Plastic suitable
for steam sterilization | Tempered Plastic suitable
For stem sterilization. |
| Sterilization method | Provided non-sterile
Recommend steam
sterilization | Provided non-sterile
Recommend steam
sterilization |
| Intended use | Distal Radius Fracture
Repair System is intended
for the fixation of fractures
and osteotomies involving
the distal radius. | Distal Radius Fracture
Repair System is intended
for the fixation of fractures
and osteotomies involving
the distal radius. |
| Implant Period | Permanent | Permanent |
| Material of Construction | Plates: Titanium | Plates: Titanium |
| Available configurations | Pegs and Screws: Titanium
and Stainless Steel
Right and Left
Volar and Dorsal | Pegs and Screws: Titanium
And Stainless Steel
Right and Left
Volar and Dorsal |
| No. of buttress pegs | 5 each size | 5 each size |
| No. of Cortex Screws | 8 each size | 8 each size |
| Buttress Peg Length mm | 16, 18, 20, 22, 24, 26, 28 | 16, 18, 20, 22, 24, 26, 28 |
| Cortex Screw Length mm | 10, 12, 14, 16, 18 | 10, 12, 14, 16, 18 |
| Specialized instruments
included in tray | Bending tool
Drill Guide
Depth Gauge
Peg Driver
Screw Driver
DNP Jig Right & Left | Bending Tool
Drill Guide
Depth Gage
Peg Driver
Screw Driver
DNP Jig Right & Left |
| Tool and component
separators and holders in
tray | Yes | Yes |
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 1 2003
Hand Innovations, Inc. c/o Mr. Richard D. Bliss, Jr. Ouality System Engineering 510 Stonemont Drive Weston, Fl 33326
Re: K030198
Trade Name: Distal Radius Fracture Repair System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: January 20, 2003 Received: January 21, 2003
Dear Mr. Bliss:
We have reviewed your Section 510(k) premarket 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) 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.
5
Page 2 - Mr. Richard D. Bliss, Jr.
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Mark A. Mckennon
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
6
030198
Device Name:
Distal Radius Fracture Repair System
Indications for Use:
The Distal Radius Fracture Repair System is intended for the fixation of fractures and osteotomies involving the distal radius.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use or Over-The-Counter Use (Pre 21 CFR 801.109) (Optional Format 1-2-96)
Mark A. Milliman
ivision Sign-Off) Division of General, Restorative al Devices
90(k) Number __ K030198