(15 days)
Not Found
Not Found
No
The device description and intended use clearly describe a mechanical implant (screw) for bone fixation. There is no mention of software, algorithms, or any technology that would incorporate AI or ML.
Yes
The device is indicated for "fixation of bone fractures or for bone reconstruction," which are therapeutic interventions.
No
The device is a compression screw used for bone fixation and reconstruction, not for diagnosis. Its intended uses involve treatment of fractures and bone reconstruction, not identifying or diagnosing conditions.
No
The device description clearly states it is a physical screw manufactured from Titanium Alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the DARCO® Headless Compression Screw clearly state that it is a surgical implant used for the fixation and reconstruction of bone fractures and osteotomies. It is a physical device implanted into the body to provide structural support.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens.
Therefore, based on the provided information, the DARCO® Headless Compression Screw is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 7.0mm DARCO® Headless Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Fixation of bone fragments, in long bones or small bones fractures .
- Fracture management in the foot or hand .
- Arthrodesis in hand, foot or ankle surgery
- Mono or Bi-cortical osteotomies in the foot or hand or in long bones
- . Treatment of inferior tibio fibular diastasis
- . Hindfoot arthrodesis
The 4.3mm DARCO® Headless Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- · Mono or Bi-Cortical osteotomies in the foot or hand
- · Distal or Proximal metatarsal or metacarpal osteotomies
- · Weil osteotomy
- · Fusion of the first metatarsophalangeal joint and interphalangeal joint
- · Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- · Akin type osteotomy
- Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
- · Calcaneus/ cuboid arthrodesis
- · Talar/ navicular arthrodesis
Product codes
HWC
Device Description
The DARCO® Headless Compression Screw is manufactured from Titanium Alloy conforming to ASTM F136. The screws are offered in varying overall lengths and thread lengths to accommodate variability among patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones, small bones, foot, hand, ankle, metatarsals, metacarpals, calcaneus, cuboid, talar, navicular
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)
The safety and effectiveness of the DARCO® Headless Compression Screw is adequately supported by the substantial equivalence information, matcrials information, and analysis data provided within this Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K080850 pg lot 2
510(K) SUMMARY APR 1 0 2008 OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the DARCO® Headless Compression Screw.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | February 28, 2008 |
| Contact Person: | Theresa Leister |
| Senior Regulatory Affairs Specialist | |
| Proprietary Name: | DARCO® Headless Compression Screw |
| Common Name: | Compression Screw |
| Classification Name and Reference: | 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/HWC |
DEVICE INFORMATION
A. INTENDED USE
The 7.0mm DARCO® Headless Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Fixation of bone fragments, in long bones or small bones fractures .
- Fracture management in the foot or hand .
- Arthrodesis in hand, foot or ankle surgery
- Mono or Bi-cortical osteotomies in the foot or hand or in long bones
- . Treatment of inferior tibio fibular diastasis
- . Hindfoot arthrodesis
The 4.3mm DARCO® Headless Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- · Mono or Bi-Cortical osteotomies in the foot or hand
- · Distal or Proximal metatarsal or metacarpal osteotomies
- · Weil osteotomy
- · Fusion of the first metatarsophalangeal joint and interphalangeal joint
- · Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- · Akin type osteotomy
1
-
Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
-
· Calcaneus/ cuboid arthrodesis
-
· Talar/ navicular arthrodesis
B. DEVICE DESCRIPTION
The DARCO® Headless Compression Screw is manufactured from Titanium Alloy conforming to ASTM F136. The screws are offered in varying overall lengths and thread lengths to accommodate variability among patients.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features, material, and indications for use of the DARCO® Headless Compression Screw are substantially equivalent to previously cleared predicate device. The safety and effectiveness of the DARCO® Headless Compression Screw is adequately supported by the substantial equivalence information, matcrials information, and analysis data provided within this Premarket Notification.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wright Medical Technology, Inc. % Ms. Theresa Leister 5677 Airline Road Arlington, TN 38002
APR 1 0 2008
Re: K080850 Trade/Device Name: DARCO Headless Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 28, 2008 Received: March 26, 2008
Dear Ms. Leister:
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 - Ms. Theresa Leister
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: DARCO® Headless Compression Screw
Indications For Use:
The 7.0mm DARCO® Headless Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Fixation of bone fragments, in long bones or small bones fractures ●
- Fracture management in the foot or hand ●
- Arthrodesis in hand, foot or ankle surgery �
- Mono or Bi-cortical osteotomies in the foot or hand or in long bones ●
- . Treatment of inferior tibio fibular diastasis
- t Hindfoot arthrodesis
The 4.3mm DARCO® Headless Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Mono or Bi-Cortical osteotomies in the foot or hand .
- Distal or Proximal metatarsal or metacarpal osteotomies .
- Weil osteotomy .
- Fusion of the first metatarsophalangeal joint and interphalangeal joint �
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) �
- . Akin type osteotomy
- Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus . varus primus
- Calcaneus/ cuboid arthrodesis .
- Talar/ navicular arthrodesis .
Prescription Use (Part 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 G e Evaluation (ODE)
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K080850
1 of 1