(69 days)
Not Found
No
The device description and intended use clearly describe a physical orthopedic screw for bone fixation. There is no mention of software, algorithms, or any technology that would incorporate AI or ML.
Yes
The device is intended for the fixation of bone fractures, fusion of a joint, or bone reconstructions, which are therapeutic interventions.
No
Explanation: The DePuy FRS-Screw is an orthopedic implant for fixation of bone fractures and reconstruction, not for diagnosing medical conditions.
No
The device description explicitly states it is a "cannulated thread-head screw made of a Titanium alloy," which is a physical hardware component.
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 bone fractures, fusion of a joint, or bone reconstructions. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a cannulated thread-head screw made of a Titanium alloy, designed to be implanted.
- Anatomical Site: The device is used in specific anatomical locations within the foot and hand.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device is implanted into the body for structural support and fixation.
N/A
Intended Use / Indications for Use
Intended Use:
The DePuy FRS-Screw is intended to be implanted for the fixation of bone fractures, fusion of a joint or bone reconstructions.
Indications for Use:
The FRS®-Screw is indicated for fixation of bone fractures, fusion of a joint, or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals, and carpals of the hand. Examples include:
. Hallux Valgus correction
פי Akin Osteotomies
MTP arthrodesis
E Interphalangeal arthrodesis
Product codes (comma separated list FDA assigned to the subject device)
87 HWC
Device Description
The DePuy FRS-Screw is a cannulated thread-head screw made of a Titanium alloy and is available in lengths of 10-34mm in 2mm increments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals, and carpals of the hand.
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)
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
§ 888.3040 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
Kα62352
510(k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93) OCT 1 9 2006
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46582
Establishment Registration Number: 1818910 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Rebecca Lennard
Regulatory Affairs Associate II
Telephone: (574) 372-5023
Facsimile: (574) 371-4987
Electronic Mail: RLennard@dpyus.jnj.com |
| DATE PREPARED: | May 24, 2006 |
| PROPRIETARY NAME: | FRS® Screw |
| COMMON NAME: | Bone Fixation Screw |
| CLASSIFICATION: | Class II device per 21 CFR 888.3040: Smooth or threaded bone fixation fastener |
| DEVICE PRODUCT CODE: | 87 HWC |
| SUBSTANTIALLY EQUIVALENT
DEVICES: | DePuy SCARF THREAD-HEAD™ SCREW,
K962236, cleared on September 20, 1996
NewDeal SA BOLD® Screw,
K011262, cleared on June 15, 2001 |
| DEVICE DESCRIPTION: | |
DEVICE DESCRIPTION:
The DePuy FRS-Screw is a cannulated thread-head screw made of a Titanium alloy and is available in lengths of 10-34mm in 2mm increments.
INTENDED USE AND INDICATIONS:
Intended Use:
The DePuy FRS-Screw is intended to be implanted for the fixation of bone fractures, fusion of a joint or bone reconstructions.
Indications for Use:
The FRS®-Screw is indicated for fixation of bone fractures, fusion of a joint, or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals, and carpals of the hand. Examples include:
- . Hallux Valgus correction
- 피 Akin Osteotomies
1
- MTP arthrodesis
- E Interphalangeal arthrodesis
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy FRS®-Screw devices described in this submission are substantially equivalent to the predicate devices based on similarities in intended use, indications for use, materials and design.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2006
DePuy Orthopaedics, Inc. % Ms. Rebecca Lennard 700 Orthopaedic Drive Warsaw. Indiana 46582
Re: K062352
Trade/Device Name: FRS® Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 10, 2006 Received: August 11, 2006
Dear Ms. Lennard:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Rebecca Lennard
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 (240) 276-0120 . 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/industry/support/index.html.
Sincerely vours.
$\mathbb{P}{k} \mathbb{P}{k}^{1/2}$
Mark N. Melkerson Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510 (k) Number (if known):
FRS®-Screw Device Name:
Indications for Use:
The FRS®-Screw is indicated for fixation of bone fractures, fusion of a joint, or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals, and carpals of the hand. Examples include:
- Hallux Valgus correction 트
- 트 Akin Osteotomies
- 체 MTP arthrodesis
- 1 Interphalangeal arthrodesis
(Please do not write below this line - continue on another page if necessary)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
Over-The-Counter-Use:
OR
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number LC(125)
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