(87 days)
No
The device description focuses on mechanical components (plates, screws, pegs, jigs) and materials used for fracture fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "Distal Radius Fracture Repair Kit" intended for the "fixation of fractures and osteotomies involving the distal radius," clearly indicating its use in treating a medical condition.
No
This device is a surgical implant designed for the fixation of fractures and osteotomies, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of titanium and stainless steel, including plates, screws, pegs, and surgical instruments. There is no mention of software as a component of this system.
Based on the provided text, 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 to repair bone, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The device is described as an "implantable orthopedic nail-plate device" and includes components like plates, screws, pegs, and surgical instruments. These are all used directly on the patient during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a surgical implant and associated instruments, not an In Vitro Diagnostic device.
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
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 consists of the Distal Volar Fracture Repair System. which was previously cleared under 510(k) No. K002775. The system comprises volar stabilization plate, bone, screws, and fixation pegs. This 510(k) is being submitted as a modification to the original 510(k) No. K002775 to allow for the dorsal fixation of stable fractures of the distal radius. A copy of the clearance letter is enclosed with this submission.
The Distal Dorsal Nail Plate (DNP) (left and right) is an implantable orthopedic nail-plate device used for the fixation of distal radius fractures. This device permits fixation of distal radius fractures with a minimal incision on the dorsal side while avoiding the tendon adhesion problems. The device consists of a plate portion, which offsets into a nail portion, all cut out of a solid piece of titanium (Titanium TI-6AL-4V ELI anodized Type II). The plate portion is narrow (~6mm) and long (~16mm) and has 3 threaded holes for the attachment of pegs with bending load capacity. These holds are appropriately angled so the pegs fan out and support the distal fracture fragment near the articular surface. The nail portion starts thick and tapers into a long, flexible section. At the start of the taper there are 2 crossing holes spaced about 9 mm apart. The holes are sized to fit 2.5 mm screws, which are used to anchor the nail-plate to the radius proximal of the fracture. The pegs, standard or threaded, and the 2.5mm screws are driven with the Peg Driver. The anchor screws and pegs are available in different lengths to accommodate most patient anatomies and fracture morphologies.
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 quide.
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 Dorsal Nail Plate and Jig Set include the following:
| Name | Part No. | Material Composition |
|---|---|---|
| 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/ | 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/ | Titanium TI-6AL-4V ELI |
| Screw, 2.5mm (14,16,18, | ||
| 20,22,24,26,28mm) | DRW-034/ | |
| 039, DRW-059/DRW- | ||
| 060 (Table DRW-027) | 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.
See Modification of Device Section for the Kit Manufacturer's Certification Statement containing a complete listing of all components.
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.
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
K023007
10Fy
510(k) Summary of Safety and Effectiveness
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 consists of the Distal Volar Fracture Repair System. which was previously cleared under 510(k) No. K002775. The system comprises volar stabilization plate, bone, screws, and fixation pegs. This 510(k) is being submitted as a modification to the original 510(k) No. K002775 to allow for the dorsal fixation of stable fractures of the distal radius. A copy of the clearance letter is enclosed with this submission.
The Distal Dorsal Nail Plate (DNP) (left and right) is an implantable orthopedic nail-plate device used for the fixation of distal radius fractures. This device permits fixation of distal radius fractures with a minimal incision on the dorsal side while avoiding the tendon adhesion problems. The device consists of a plate portion, which offsets into a nail portion, all cut out of a solid piece of titanium (Titanium TI-6AL-4V ELI anodized Type II). The plate portion is narrow (~6mm) and long (~16mm) and has 3 threaded holes for the attachment of pegs with bending load capacity. These holds are appropriately angled so the pegs fan out and support the distal fracture fragment near the articular surface. The nail portion starts thick and tapers into a long, flexible section. At the start of the taper there are 2 crossing holes spaced about 9 mm apart. The holes are sized to fit 2.5 mm screws, which are used to anchor the nail-plate to the radius proximal of the fracture. The pegs, standard or threaded, and the 2.5mm screws
1
are driven with the Peg Driver. The anchor screws and pegs are available in different lengths to accommodate most patient anatomies and fracture morphologies.
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 quide.
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 Dorsal Nail Plate and Jig Set include the following:
| Name | Part No. | Material Composition |
|---|---|---|
| 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/ | 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/ | Titanium TI-6AL-4V ELI |
| Screw, 2.5mm (14,16,18, | ||
| 20,22,24,26,28mm) | DRW-034/ | |
| 039, DRW-059/DRW- | ||
| 060 (Table DRW-027) | 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. |
2
| 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.
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 Synthes Distal Radius Plate System, 510(k) No. K982732, with regard to the intended use, materials, biocompatibility and overall performance characteristics. The current labeling for the Distal Volar Radius Fracture Repair System has been modified to include the components for the Distal Dorsal Nail Plate. As previously mentioned, the name of the combined product has changed to accommodate this modification.
3
4 OF 4
Summary of Substantial Equivalence
| Feature | Distal Radius Fracture
Repair Kit | Distal Radius Plate
Instrument and Implant
Set
(Predicate Device) |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hand Innovations, Inc. | Synthes USA |
| Packaging | Tempered Plastic suitable
for steam sterilization | Stainless steel tray suitable
for steam 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. | The Synthes Distal Radius
Plate System is intended for
fixation of fractures,
osteotomies, including
carpal fusions involving the
distal radius applied to the
volar and dorsal aspects. |
| Implant Period | Permanent | Permanent |
| Material of Construction | Plates: Titanium
Pegs and Screws: Titanium
and Stainless Steel | Plates: Stainless Steel and
Titanium Alloy
Pegs and Screws: Stainless
Steel and Titanium Alloy |
| Available configurations | Right and Left
Volar and Dorsal | Right and Left
Volar and Dorsal |
| No. of buttress pegs | 5 each size | 6 maximum |
| No. of Cortex Screws | 8 each size | 6 maximum |
| Buttress Peg Length mm | 16, 18, 20, 22, 24, 26, 28 | Trim to desired length |
| Cortex Screw Length mm | 10, 12, 14, 16, 18 | 10 to 26 |
| Specialized instruments
included in tray | Bending tool
Drill Guide
Depth Gauge
Peg Driver
Screw Driver
DNP Jig Right & Left | Bending Pliers and Irons
Drill Guide
Depth Gage
Peg Driver
Screw Driver |
| Tool and component
separators and holders in
tray | Yes | Yes |
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized design that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Public Health Service
DEC 0 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hand Innovations, Inc c/o Mr. Richard D. Bliss, Jr. Quality Systems Engineering, Inc. 510 Stonemont Drive Weston, Florida 33326
Re: K023007
Trade/Device Name: Distal Radius Fracture Repair System Regulation Numbers: 21 CFR 888.3030 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: September 4, 2002 Received: September 9, 2002
Dear Mr. Bliss:
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 mav 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
5
Page 2 – Mr. Richard D. Bliss, Jr.
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.
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. 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 N Millman
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
Device Name:
Distal Radius Fracture Repair System
(The original name for this device, Distal Volar Radius Fracture Repair System that cleared FDA under 510(k) No. K002775, is being modified to accommodate both the Volar and the Dorsal fixation of distal radius fractures.)
Indications for Use:
The Distal Radius Fracture Repair System is intended for the fixation of fractures and osteotomies involving the distal radius.
This 510(k) submission will address the only the additional indication for use
(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)
for Mark N Milkus
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number _**_ K023007
00000