(41 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical, describing a surgical screw. There is no mention of software, algorithms, or any computational processing that would suggest AI/ML.
No.
The device is a surgical implant (headless compression screws) used for fixation of fractures and non-unions, which falls under orthopedic fixation rather than therapeutic treatment.
No
The device is a headless compression screw, used for fixation of fractures and non-unions, arthrodeses, bunionectomies, and osteotomies. It is a surgical implant, not a tool for diagnosis.
No
The device description clearly states it is a physical screw made of Stainless Steel or Titanium Alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Synthes 3.0 mm Headless Compression Screws are for the fixation of fractures and non-unions of bones and joints. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implantable device (screws) used in surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. This device does not do that.
The information provided describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Synthes 3.0 mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodeses of small joints; bunionectomies and ostetotomies. Examples include, but are not limited to scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
Product codes
HWC
Device Description
The Synthes 3.0 mm Headless Compression Screws are cannulated and are self-drilling / self-tapping with a stardrive mechanism, and have a threaded head which can be countersunk into the bone. The screws are available in short and long thread lengths ranging from 10 mm to 40 mm. The screws are available in Stainless Steel and a Titanium Alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodeses of small joints; bunionectomies and ostetotomies. Examples include, but are not limited to scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
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)
Synthes 3.0 mm Sterile 3.0 mm Cannulated Screw and Threaded Washer
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
KOSD636
Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line runs underneath the word and logo. There is a registered trademark symbol to the right of the word.
APR 2 1 2005
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| 1302 Wrights Lane East | ||
| West Chester, PA 19380 | ||
| (610) 719-5000 | ||
| Device Name: | Synthes 3.0mm Headless Compression Screws | |
| Classification: | 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation | |
| Fastener. | ||
| Predicate Devices: | Synthes 3.0 mm Sterile 3.0 mm Cannulated Screw and Threaded | |
| Washer | ||
| Device Description: | The Synthes 3.0 mm Headless Compression Screws are cannulated | |
| and are self-drilling / self-tapping with a stardrive mechanism, and | ||
| have a threaded head which can be countersunk into the bone. The | ||
| screws are available in short and long thread lengths ranging from | ||
| 10 mm to 40 mm. The screws are available in Stainless Steel and a | ||
| Titanium Alloy. | ||
| Intended Use: | The Synthes 3.0 mm Headless Compression Screws are intended | |
| for fixation of intra-articular and extra-articular fractures and non- | ||
| unions of small bones and small bone fragments; arthrodeses of | ||
| small joints; bunionectomies and ostetotomies. Examples include, | ||
| but are not limited to scaphoid and other carpal bones, metacarpals, | ||
| tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head | ||
| and radial styloid. | ||
| Substantial | ||
| Equivalence: | Information presented supports substantial equivalence. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2005
Ms. Sheri L. Musgnung Senior Regulatory Specialist Synthes (USA) 1302 Wrights Lane West Chester, Pennsylvania 19380
Re: K050636
Trade/Device Name: Synthes (USA) 3.0 mm Headless Compression Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 10, 2005 Received: March 11, 2005
Dear Ms. Musgnung:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocures in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manation in the Medical Device Amendments, or to Conniered price to May 20, 1978, in eccordance with the provisions of the Federal Food, Drug, devices that have been rochasined in avere approval of a premarket approval application (PMA). and Cosmetic 71ct (11ct) that do not request in the general controls provisions of the Act. The Tou may, uteretore, market are as act include requirements for annual registration, listing of gencial controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is eassified (dee ass ( ) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = it may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oode of Peachards concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I DA 3 issuates or our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of ally it cochal statutes and regarations ancluding, but not limited to: registration and listing (21 comply with an the Act 31equirements, nieteams, and manufacturing practice requirements as set CTN in the quality systems (QS) certer an 800); and If applicable, the electronic a form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2- Ms. Sheri L. Musgnung
This letter will allow you to begin marketing your device as described in your Section 5 0(k) I his letter will anow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of the s premarket notification: "The PDF Imaning sification 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 If you desire specific advice for your do not to read to car and the regulation entitled, the regulation Contact the Office of Comphalled at (210) = 16 = 16 = 1 = 1 807.97). You may obtain "Misbranding by reletence to premarket noultied.com the Act from the Division of Small other general information on your responsion.com its toll-free number (800) 638-2041 or and findex bird Manufacturers, Internet and Consailer risolors of the cov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line is present below the word, adding a sense of completion to the design. The registered trademark symbol is located to the right of the word.
of Page 1
Indications for Use
510(k) Number (if known):
Synthes (USA) 3.0 mm Headless Compression Screws
Indications for Use:
Device Name:
2.0
The Synthes 3.0 mm Headless Compression Screws are intended for fixation of intra-articular
1.0 mm Headless Compression of world hones and small bones fragments: The Synthes 3.0 mm Headless Compression of small bones and small bones fragments;
and extra-articular fractures and non-unions of small bones include, hul a and extra-articular fractures and noll-miss and osteologies. Examples include, but are not
arthrodeses of small joints; bunionectomies and osterolo materas; patella, ulpar arthrodeses of small joints; outlouccomes and corocolorized = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = minted to soapitellum, radial head and radial styloid.
Prescription Use _ X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Styd Clurlo
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign-( Diff (Division Division of Seneral, Restorative and Nourological Devices
510(K) Number: K050636