(90 days)
Synthes Schanz Screws and Smith & Nephew Jet-X Half Pin.
Not Found
No
The summary describes a mechanical device (screws) with a coating, and there is no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is used to fix fractures and correct deformities in long bones, which are therapeutic applications.
No
The device, Synthes HA Coated Schanz Screws, is described as being "intended for use with an external fixation system for fracture fixation...pseudoarthrosis or non-union of long bones; limb lengthening...correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis." This indicates it is a therapeutic or surgical device, not one that diagnoses a condition.
No
The device description clearly states it is a physical implant (Schanz Screws) with a coating, not a software product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (Schanz Screws) used for bone fixation and correction. It is a physical device implanted into the body, not a device that analyzes biological samples outside the body.
The description focuses on the mechanical properties and application of the screw for orthopedic procedures, which is the domain of surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
"Synthes HA Coated Schanz Screws are intended for use in an external fixation system for fracture fixation (open and closed); pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis."
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
"Synthes HA Coated Schanz Screws are available as self-drilling and non-self-drilling designs. The HA Coated Schanz Screws are available in a variety of diameters and lengths. The threaded portion of the schanz screw is coated with a very thin plasma sprayed coating of HA."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones (fracture fixation, pseudoarthrosis or non-union, limb lengthening), bony or soft tissue (deformity, defects), joints (arthrodesis)
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.
Synthes Schanz Screws and Smith & Nephew Jet-X Half Pin.
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
143
| 3. 510(k) Summary: | K040701 |
|---|---|
| Sponsor: | Synthes (USA) |
| 1690 Russell Road | |
| Paoli, PA 19301 | |
| (610) 647-9700 | |
| Contact: | Sheri L. Musgnung |
| Device Name: | Synthes (USA) Hydroxyapatite (HA) Coated Schanz Screws |
| Device Classification: | 21 CFR 888.3040 – “Smooth or threaded metallic bone |
| fixation fastener” | |
| Predicate Device: | Synthes Schanz Screws and Smith & Nephew Jet-X Half Pin. |
| Description of Device: | Synthes HA Coated Schanz Screws are available as self-drilling and |
| non-self-drilling designs. The HA Coated Schanz Screws are | |
| available in a variety of diameters and lengths. The threaded portion | |
| of the schanz screw is coated with a very thin plasma sprayed coating | |
| of HA. | |
| Indications: | Synthes HA Coated Schanz Screws are intended for use in an external |
| fixation system for fracture fixation (open and closed); | |
| pseudoarthrosis or non-union of long bones; limb lengthening by | |
| epiphyseal or metaphyseal distraction; correction of bony or soft tissue | |
| deformity; correction of segmental bony or soft tissue defects; and | |
| joint arthrodesis. | |
| Material: | Titanium and stainless steel |
| Substantial Equivalence: | Documentation is provided which demonstrates that the Synthes HA |
| Coated Schanz Screws is substantially equivalent* to other legally | |
| marketed devices. |
- The term “substantially equivalent” as used in this 510(k) notification is
limited to the definition of substantial equivalence found in the Food, Drug,
and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E,
under which a device can be marketed without pre-market approval or
reclassification. A determination of substantial equivalency under this
notification is not intended to have any bearing whatsoever on the resolution
of patent infringement suits or any other patent matter. No statements related
to, or in support of substantial equivalence herein shall be construed as an
admission against interest under the US Patent Laws or their application by the
courts.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 2004
Sheri L. Musgnung Synthes (USA) 1690 Russel Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K040701
Trade/Device Name: Synthes Hydroxyapatite (HA) Coated Schanz Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: II Product Code: HWC Dated: March 16, 2004 Received: March 17, 2004
Dear Ms. Musgnung:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the 1125 2011 11:14 accordance with the provisions of the Federal Food, Drug, de vices that have been received in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, morelore, mains of the Act include requirements for annual registration, listing of general controls profise wing 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 If your device is classined (600 as cotrols. Existing major regulations affecting your device can may oe our re-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 I lease be actived that I Dr untion that your device complies with other requirements of the Act that I Dri has made a availations administered by other Federal agencies. You must or any I caetar buttates and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT an 6077, adoling (21 OFF earlation (21 CFR Part 820); and if applicable, the electronic form in the quisions would provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 – Sheri L. Musgnung
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and h yourse FDA finding of substantial equivalence of your device to a legally premaince notification " 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 If you desire specific acceants at (301) 594-4659. Also, please note the regulation entitled, Connect the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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 yours,
Miriam C. Provost
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
3
2. Indications for Use
:
Page __ 1__ of _______________________________________________________________________________________________________________________________________________________________
| 510(k) Number (if known): | K040701 |
|---|---|
| Device Name: | Synthes Hydroxyapatite (HA) Coated Schanz Screws |
| Indications for Use: | Synthes Hydroxyapatite (HA) Coated Schanz Screws are |
| intended for use with an external fixation system for | |
| fracture fixation (open and closed); pseudoarthrosis or | |
| non-union of long bones; limb lengthening by | |
| epiphyseal or metaphyseal distraction; correction of | |
| bony or soft tissue deformity; correction of segmental | |
| bony or soft tissue defects; and joint arthrodesis. |
:
Prescription Use _____________________________________________________________________________________________________________________________________________________________
:
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Miriam C. Provost
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| Synthes (USA) HA Coated Schanz Screw 510(k) Number | K040701 |
|---|---|
| ---------------------------------------------------- | --------- |
000004