(41 days)
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.
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.
The provided text is a 510(k) summary and FDA clearance letter for the Synthes 3.0 mm Headless Compression Screws. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical trial reports or performance testing documentation.
The 510(k) pathway for medical device clearance is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than on proving performance against specific acceptance criteria through extensive clinical studies in the same way a PMA (Premarket Approval) would.
Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory clearance based on equivalence rather than detailed performance study results against predefined acceptance metrics.
Here's an explanation of why the requested information isn't available in this document type:
- Acceptance Criteria & Device Performance Table: This type of detail would typically be found in a performance testing report (e.g., mechanical testing, biocompatibility testing) or a clinical study report. The 510(k) summary doesn't include these specific performance metrics or a table comparing them to acceptance criteria.
- Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance, Ground Truth Type for Test Set, Training Set Sample Size, Training Set Ground Truth: All these points relate to specific clinical study design and execution, which are not detailed in a 510(k) submission unless it's a very complex device requiring specific clinical data for equivalence, or if a new indication requires it. For a bone screw, the primary evidence relies on existing predicate devices, material properties, and mechanical testing.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence, not a performance study report.
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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 EastWest Chester, PA 19380(610) 719-5000 | |
| Device Name: | Synthes 3.0mm Headless Compression Screws | |
| Classification: | 21 CFR 888.3040: Smooth or Threaded Metallic Bone FixationFastener. | |
| Predicate Devices: | Synthes 3.0 mm Sterile 3.0 mm Cannulated Screw and ThreadedWasher | |
| Device Description: | The Synthes 3.0 mm Headless Compression Screws are cannulatedand are self-drilling / self-tapping with a stardrive mechanism, andhave a threaded head which can be countersunk into the bone. Thescrews are available in short and long thread lengths ranging from10 mm to 40 mm. The screws are available in Stainless Steel and aTitanium Alloy. | |
| Intended Use: | The Synthes 3.0 mm Headless Compression Screws are intendedfor fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodeses ofsmall joints; bunionectomies and ostetotomies. Examples include,but are not limited to scaphoid and other carpal bones, metacarpals,tarsals, metatarsals, patella, ulnar styloid, capitellum, radial headand radial styloid. | |
| SubstantialEquivalence: | Information presented supports substantial equivalence. |
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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.
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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
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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
§ 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.