(8 days)
Not Found
No
The 510(k) summary describes a standard bone screw system made of titanium, with no mention of software, algorithms, image processing, AI, ML, or any related concepts. The description focuses solely on the physical characteristics and intended use of the screws.
No
The device is a bone screw system used for fixation of fractures, fusions, or osteotomies, which falls under surgical orthopedic implants rather than devices designed to cure, treat, mitigate, or prevent disease through non-invasive therapeutic means.
No
Explanation: The device description states its purpose is for "fixation of fractures, fusions, or osteotomies of bones," which is a treatment/surgical function, not a diagnostic one.
No
The device description clearly states it consists of screws made of Titanium, which are physical hardware components intended for implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Nexa Bone Screw System Function: The Nexa bone screw system is an implantable device used for the fixation of bones within the body. It is a surgical device, not a diagnostic test performed on samples.
The provided information clearly describes a surgical implant used for structural support, which is fundamentally different from the function of an IVD.
N/A
Intended Use / Indications for Use
The Nexa bone screw system provides fixation of fractures, fusions, or osteotomies of bones of the hand and foot.
Product codes
87 HWC
Device Description
The Nexa Orthopedics bone screw system consists of screws made of Titanium (6AL-4V ELI) intended to be implanted into the bones of the foot, and hand. The screws are provided in 6 sizes. The screws are used for fixation of fractures, fusions, or osteotomies of bones of the hand and foot. The design of the Nexa bone screw system is similar in shape and size to the Wright Medical Charlotte Snap-Off Screw. No new materials arc used in the development of this implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the hand and foot
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)
K043583 - Charlotte Snap-off Screw System
Reference Device(s)
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
K053394 r½
510 (k) Summary
DEC 1 4 2005
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
| Prepared: | December 6, 2005 |
|---|---|
| Applicant: | Nexa Orthopedics, Inc., (dba Futura |
| Biomedical, LLC) | |
| 10675 Sorrento Valley Road, Suite 100 | |
| San Diego, CA 92121 | |
| Telephone: | 858-866-0660 |
| Fax: | 858-866-0661 |
| Contact: | Louise M. Focht |
| Device Name: | Nexa bone screw system |
| Device Trade Name: | Nexa bone screw system |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number | 888.3040 |
| Product Code: | 87 HWC |
| Predicate Device: | K043583 - Charlotte Snap-off Screw |
| System | |
| Registration Number: | 2030833 |
| Owner Operator Number: | 9028319 |
Device Description:
The Nexa Orthopedics bone screw system consists of screws made of Titanium (6AL-4V ELI) intended to be implanted into the bones of the foot, and hand. The screws are provided in 6 sizes. The screws are used for fixation of fractures, fusions, or osteotomies of bones of the hand and foot. The design of the Nexa bone screw system is similar in shape and size to the Wright Medical Charlotte Snap-Off Screw. No new materials arc used in the development of this implant.
Indications for Use:
The Nexa bone screw system provides fixation of fractures, fusions, or osteotomics of bones of the hand and foot.
Comparison to Predicate Device:
1
KC53374 P²/₂
The legally marketed predicate device to which this device is substantially equivalent is the Wright Medical Charlotte Snap-Off Screw
Regulatory Class: II 87 HWC Product Code:
Table 1. Comparison of Nexa Orthopedics and Wright Medical Snap off screw.
| Item | Nexa Orthopedics | Wright Medical |
|---|---|---|
| Product Name | Nexa bone screw system | Charlotte Snap-Off Screw |
| Use | Single use | Single use |
| Fixation | Screw | Screw |
| Material | Titanium 6AL-4V ELI | Titanium alloy 6AL-4V |
| Sizes | 6 sizes | 3 sizes |
| Indications for use | The Nexa bone screw system provides fixation for fractures, fusions, or osteotomies of bones of the hand and foot. | The Charlotte Snap Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: |
| Fixation of Small Bone Fragments | ||
| Weil osteotomy | ||
| Mono-cortical fixation | ||
| Osteotomies and fractures fixation in the foot and hand. |
Similarities of the Nexa Orthopedics bone screw system and Wright Medical Snap-Off Screw include:
Both devices are: intended for single use only; intended for surgical implantation longer than 30 days; both devices are screws for fixation of fractures, fusions, or osteotomies, of bones of the hand and foot; both devices are made of industry standard materials, no new materials are introduced in either product; Both devices are comparably sized; both devices have the same indications for use.
Summary:
The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the wings and a snake-like form at the bottom. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2005
Mr. Louise M. Focht Nexa Orthopedics, Inc., 10675 Sorrento Valley Road, Suite 100 San Diego, California 92121
Re: K053394
Trade/Device Name: Nexa bone screw system Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: II Product Code: HWC Dated: December 5, 2005 Received: December 6, 2005
Dear Mr. Focht:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 9 ro(x) premained in substantially equivalent (for the indications referenced above and have determined the arrest of the devices marketed in interstate for use stated in the encrosule) to regary maneroup of the Medical Device Amendments, or to commerce prior to May 28, 1970, the charger and the Federal Food, Drug, 1994, Drug, devices that have been reclassified in accerance wear a premarket approval application (PMA).)
and Cosmetic Act (Act) that do not require approval of a premisions of the Act, and Cosment Act (Act) that do not require the general controls provisions of the Act. The You may, merelore, market the devices, belject of the ments for annual registration, listing of general controls provisions of the necessor 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 classified (seculove) me. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entrologically - - 000 to 898. In addition, FDA may be found in the Ood neements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issualite of wouldevice complies with other requirements of the Act
that FDA has made a determination that your device complies with other requ that IDA has made a decerminations administered by other Federal agencies. You must or any rederal statutes and regulations admiding, but not limited to: registration and listing (21 Comply with an the Free STOQuentiality, 2001 manufacturing practice requirements as set CFR in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro herems (2001) (2006) 100 marketing your device as described in your Section 510(k) This letter with anow you to begin manieting of substantial equivalence of your device to a legally
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Page 2 - Mr. Louise M. Focht
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 If you desire spoonly and (240) 276-0120. Also, please note the regulation entitled, Connect the Office of Course to premarket 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/industry/support/index.html.
Sincerely yours,
r Mark N. Melkerson Acting Director 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
510 (k) Number (If Known): K053394
Device Name: Nexa bone plate and screw system
Indications for Use:
・
The Nexa bone screw system provides fixation of fractures, fusions, or osteotomies of bones of the hand and foot.
Prescription Use X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Countor Usc (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
(Division Sign-Off)
Division of General, Reand Neurological Device
510(k) Number K053394
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