K Number
K051747
Device Name
SBI WRISTFIT
Date Cleared
2005-09-06

(69 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SBI WristFIT™ (Fracture In Tension) Distal Radius System implants are indicated in the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotomies geared towards a functionally stable osteosynthesis in small and long bones. This includes: - . distal radius fractures - t distal ulna fractures - . radial osteotomies - . radial fusions - . tarsal fractures
Device Description
The system features non-sterile stainless steel plates with cortical locking, non-locking, and Cannulated screws in two diameters (2.4mm and 2.7mm), high angle screws with low profile heads when inserted into specially designed screw holes at angles as high as 60° to 70° off perpendicular, or 30° to 70° from the plate or bone axis, and the instruments with which to implant them.
More Information

Not Found

Not Found

No
The summary describes a system of plates, screws, and instruments for orthopedic surgery, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.

Yes
The device is used in the treatment of fractures, non-unions, pseudoarthrosis, and degenerative changes, which are conditions that impair normal bodily function and require correction or cure.

No

The device description clearly states its purpose is for the "treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotomies," which are therapeutic rather than diagnostic activities.

No

The device description explicitly states it includes physical implants (plates and screws) and instruments for implantation, which are hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the device as being used for the treatment of fractures, non-unions, pseudoarthrosis, degenerative changes, and corrective osteotomies in bones. This is a therapeutic and surgical application, not a diagnostic one.
  • Device Description: The device is described as implants (plates and screws) and instruments for implantation. This aligns with surgical devices used to fix bones, not devices used to test samples from the body for diagnostic purposes.
  • 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.

Therefore, the SBI WristFIT™ (Fracture In Tension) Distal Radius System is a surgical implant system, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

SBI WristFITTM (Fracture in Tension) Distal Radius System implants are indicated in the treatment of fractures, non-unions, pseudoarthrosis, and degenerative changes as well as corrective osteotomies geared towards a functionally stable osteosynthesis is small and long bones. This includes: distal radius fractures, Distal ulna fractures, Radial osteotomies, Radial fusions, Tarsal fractures

Product codes

HRS

Device Description

The system features non-sterile stainless steel plates with cortical locking, non-locking, and Cannulated screws in two diameters (2.4mm and 2.7mm), high angle screws with low profile heads when inserted into specially designed screw holes at angles as high as 60 degrees to 70 degrees off perpendicular, or 30 degrees to 70 degrees from the plate or bone axis, and the instruments with which to implant them.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

small and long bones, distal radius, distal ulna, radial, tarsal

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

K051747

SEP - 6 2005

510(k) Summary

| Manufacturer: | Small Bone Innovations
1711 S. Pennsylvania Avenue
Morrisville, PA 19067 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Mr. Donald Guthner, Vice President
Musculoskeletal Clinical Regulatory Advisers
505 Park Avenue, 14th Floor
New York, NY 10022
dguthner@mcrallc.com
212-586-0250 - Office
212-750-2112 - Fax |
| Proprietary Name: | SBI Wrist FITTM |
| Classification name: | Class II, 888.3030 - Plate, Fixation, Bone, Non-Spinal
Class II, 888.3040 - Screw, Fixation, Bone, Non-Spinal |
| Common/Usual Name: | Internal Fixation System |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBI Wrist
FITTM to be substantially equivalent to other legally marketed
devices. |
| Device Description: | The system features non-sterile stainless steel plates with
cortical locking, non-locking, and Cannulated screws in two
diameters (2.4mm and 2.7mm), high angle screws with low
profile heads when inserted into specially designed screw holes
at angles as high as 60° to 70° off perpendicular, or 30° to 70°
from the plate or bone axis, and the instruments with which to
implant them. |
| Intended Use: | SBI WristFITTM (Fracture in Tension) Distal Radius
System implants are indicated in the treatment of fractures,
non-unions, pseudoarthrosis, and degenerative changes as
well as corrective osteotomies geared towards a
functionally stable osteosynthesis is small and long bones.
This includes: |
| | Distal radius fracturesDistal ulna fracturesRadial osteotomiesRadial fusionsTarsal fractures |
| Material: | 316L Stainless Steel |

1

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2005

Small Bone Innovations, LLC c/o Mr. Donald W. Guthner, Vice President Musculoskeletal Clinical Regulatory Advisers, LLC 505 Park Avenue, 14th Floor New York, New York 10022

Re: K051747

Trade/Device Name: SBI WristFIT™ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: June 21, 2005 Received: June 29, 2005

Dear Mr. Guthner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

2

Page 2 - Mr. Donald W. Guthner, Vice President

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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,

Sincerely yours,

Mark Mallon

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number:

Device Name: SBI WristFIT™

Indications For Use:

SBI WristFIT™ (Fracture In Tension) Distal Radius System implants are indicated in the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotomies geared towards a functionally stable osteosynthesis in small and long bones. This includes:

  • . distal radius fractures
  • t distal ulna fractures
  • . radial osteotomies
  • . radial fusions
  • . tarsal fractures

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) . .

Signature

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_KO51747