(15 days)
Not Found
No
The 510(k) summary describes a traditional orthopedic implant system (plates and screws) made of standard materials. There is no mention of software, image processing, AI, ML, or any data-driven components. The description focuses solely on the physical characteristics and intended use of the hardware.
No
The device is a bone plate and screw system intended for providing fixation during fractures, fusions, and osteotomies, which are structural and mechanical support functions rather than therapeutic in the sense of treating a disease or illness.
No
Explanation: The device is a bone plate and screw system intended for fixation during fractures, fusions, and osteotomies. It is an implantable medical device for treatment purposes, not for diagnosing medical conditions.
No
The device description explicitly states it is a "bone plate and screw system" made of physical materials (Stainless Steel and Titanium) intended for implantation. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing fixation during fractures, fusions, and osteotomies. This is a surgical intervention performed directly on the patient's body.
- Device Description: The device consists of bone plates and screws made of metal, intended to be implanted into bones. This is a medical device used for structural support and fixation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical treatment.
N/A
Intended Use / Indications for Use
The bone plate and screw system is intended for use in providing fixation during fractures, fusions and osteotomics. The system consists of plates and screws for treatment of the phalanges, and metatarsals.
Product codes
87 HRS
Device Description
The Nexa Orthopedics bone plate and screw system of plates and screws made of Stainless Steel (316L) and Titanium (6AL-4V ELI) intended to be implanted into the bones of the foot, ankle, hand, wrist, ulna and radius. The plates are provided in 4 sizes, right and left configuration. The screws are provided in 2 diameters 2.7 and 3.2 and lengths from 12-28 mm. The plates and screws are used for fracture fixation, fusion, and osteotomy of the bones of the foot.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the foot, ankle, hand, wrist, ulna and radius; phalanges, and metatarsals.
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)
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
DEC 2 2 2005
510 (k) Summary
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 plate and screw system |
| Device Trade Name: | Nexa bone plate and screw system |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number | 888.3030 |
| Product Code: | 87 HRS |
| Predicate Device: | K051884 Wright Medical Charlotte Small |
| MTP Fusion Plate | |
| K033639 Acumed Lower Extremity | |
| Congruent Plate System | |
| Registration Number: | 2030833 |
| Owner Operator Number: | 9028319 |
Device Description:
The Nexa Orthopedics bone plate and screw system of plates and screws made of Stainless Steel (316L) and Titanium (6AL-4V ELI) intended to be implanted into the bones of the foot, ankle, hand, wrist, ulna and radius. The plates are provided in 4 sizes, right and left configuration. The screws are provided in 2 diameters 2.7 and 3.2 and lengths from 12-28 mm. The plates and screws are used for fracture fixation, fusion, and osteotomy of the bones of the foot.
Indications for Use:
The bone plate and screw system is intended for use in providing fixation during fractures, fusions and osteotomics. The system consists of plates and screws for treatment of the phalanges, and metatarsals.
]
1
Comparison to Predicate Device:
The legally marketed predicate device to which this device is substantially equivalent is the Wright Medical Charlotte Small MTP Fusion Plate
Regulatory Class: II 87 HRS Product Code:
Table 1 summarizes similarities and differences between the Nexa Orthopedics and the Wright Medical Charlotte Small MTP fusion plate system.
| Item | Nexa Orthopedics System | Wright Medical Plate System |
|---|---|---|
| Product Name | Nexa bone plate and screw system | Wright Medical Charlotte Small MTP Fusion |
| Plate | ||
| Use | Single use | Single use |
| Fixation | Screw | Screw |
| Material | Stainless Steel | Stainless Steel |
| Sizes | Plates 4 sizes, right and left | |
| Screws dia 2.7mm, 3.2mm , | ||
| length 12-28mm | Plates 2 sizes, right and left | |
| Screws dia 2.7mm, 3.2mm , | ||
| length 8-24mm | ||
| Indications for use | The bone plate and screw system is intended | |
| for use in providing fixation during fractures, | ||
| fusions and osteotomies. The system | ||
| consists of plates and screws for treatment of | ||
| the phalanges, and metatarsals. | The Charlotte Small MTP Fusion Plate is | |
| intended to help increase the rate of bony | ||
| union, and to maintain the position of the toe | ||
| during fusion. Once the joint has fused, the | ||
| plate is secondary in the transmission of gait | ||
| forces. | ||
| • Fractures, osteotomies or | ||
| arthrodesis of the first metarsal- | ||
| phalangeal joint | ||
| • Deformity due to hallus valgus | ||
| • Deformity due to arthritis in the first | ||
| metatarsal-phalangeal joint | ||
| • Loss of motion-hallux rigidus | ||
| • Pain associated with osteoarthritis | ||
| or rheumatoid arthritis in the first | ||
| metatarsal-phalangeal joint | ||
| • Revision procedures where other | ||
| treatments or devices have failed; | ||
| and | ||
| • Chronic instability in the first | ||
| metatarsal-phalangeal joint |
Similarities of the Nexa Orthopedies bone plate and serew system and Charlotte small MTP Fusion Plate system include:
Both devices are: intended for single use only, intended for surgical implantation longer than 30 days; both devices are a system of plates and screws used for fixation of fracture, fusion, ostcotomics, of the metatarsal and phalangeal bones; both devices are made of
ﺰ. ﺍ
2
industry standard materials, no new materials are introduced in either product; Both madely bunnuard many 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.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 2005
Ms. Louise Focht Vice President of Research and Development Nexa Orthopedics, Inc. 10675 Sorrento Valley Road, Suite 100 San Diego, California 92121
Re: K053408
Trade/Device Name: Nexa Bone Plate and Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: December 6, 2005 Received: December 7, 2005
Dear Ms. Focht:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) premained is substantially equivalent (for the indications felerenced above and nave user.imired by marketed predicate devices marketed in interstate for use stated in the encrosule) to regally the enactment date of the Medical Device Amendments, or 10 commerce price to May 20, 1978, the ensordance with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic recry there the device, subject to the general controls provisions of the Act. The I ou may, mercrore, market the act include requirements for annual registration, listing of general controls proficious of wactice, 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 olabilition (600 a00 rols. Existing major regulations affecting your device can may be subject to sach additions, 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 nean I lease be devisou has i brinnation that your device complies with other requirements of the Act that I DA has Intact a and regulations administered by other Federal agencies. You must or any I catal suttates and regaranents, including, but not limited to: registration and listing (21
4
Page 2 - Ms. Louise Focht
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT at 607); adomig (Dr CFR Part 820); and if applicable, the electronic forul in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product lastianon only of begin marketing your device as described in your Section 510(k) This iciter will anow you to ough maing of substantial equivalence of your device to a legally premarket notification: The PDF intemsgssification 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 acriously 3 at (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 informational 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,
M. J. McFee
Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510 (k) Number (If Known):__K053408 910 (K) Names: (Nexa bone plate and screw system
Indications for Use:
The bone plate and screw system is intended for use in providing fixation during I he bolle plate and screw system is intentive a consists of plates and screws for fractures, rasible phalanges, and metatarsals bones.
Over-The-Counter Use Prescription Use _ >> AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K053408