(193 days)
Not Found
No
The summary describes a mechanical fixation system and does not mention any AI/ML components or capabilities.
Yes
The device is intended for the repair of proximal humeral fractures, which is a therapeutic intervention aimed at treating a medical condition.
No
Explanation: The device is described as a "Fixation System" intended for the repair of fractures and dislocations, indicating it is a therapeutic or reconstructive device rather than one used for diagnosis.
No
The device description explicitly lists multiple hardware components including a titanium plate, posts, screws, K-Wires, surgical instruments, and a sterilization container.
Based on the provided information, 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, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is a "Proximal Humerus Scaffold Fixation System (PHSFS)" consisting of a plate, screws, instruments, etc., intended for the repair of proximal humeral fractures. This is a surgical implant and associated tools used directly on the patient's body.
- Intended Use: The intended use is for "fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus." This describes a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant system, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Proximal Humerus Scaffold Fixation System (PHSFS) is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.
Product codes
HRS, HWC
Device Description
The Proximal Humerus Scaffold Fixation System (PHSFS) is intended for the repair of proximal humeral fractures. The system consists of a titanium plate, posts, cross-pegs, cortical screws, 1.5 mm K-Wires, manual surgical instruments, alignment fixture and a custom sterilization container.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humerus
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
The TOBY Orthopaedics Proximal Humerus Scaffold Fixation System (PHSFS) complies with the requirements of listed FDA Recognized Consensus Standards.
- ASTM F136-02a, Standard Specification for Wrought Titanium-6 Alumi-num-4 . Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401))
- ASTM F899-07, Standard Specification for Stainless Steel for Surgical In-. struments
The TOBY Orthopaedics Proximal Humerus Scaffold Fixation System (PHSFS) is substantially equivalent to Synthes LCP Proximal Humerus Plate that is legally marketed and distributed by Synthes (USA) This has been demonstrated through a 15-point technological comparison of features and a multi-parameter comparison of mechanical performance.
The implantable and tissue contact materials used to fabricate the Proximal Humerus Scaffold Fixation System (PHSFS) and Instruments have a long history of safe usage in medical devices. Because the TOBY Orthopaedics Proximal Humerus Scaffold Fixation System (PHSFS)s meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Synthes LCP Proximal Humerus Plate
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
Image /page/0/Figure/2 description: This document is a summary of safety and effectiveness for the Proximal Humerus Scaffold Fixation System (PHSFS). It was submitted by TOBY Orthopaedics, located at 3773 Matheson Avenue in Miami, Florida 33133, with the phone number 1 (305) 495-3115. The document is dated December 19, 2008, and the contact person is Al Weisenborn. The device trade name is Proximal Humerus Scaffold Fixation System (PHSFS), the common name is Shoulder Plate, and the classification name is Single/multiple component metallic bone fixation appliances and accessories per 21 CFR § 888.3030.
Identification of a Legally Marketed Predicate Device
The TOBY Orthopaedics Proximal Humerus Scaffold Fixation System (PHSFS) is substantially equivalent to Synthes LCP Proximal Humerus Plate that is legally marketed and distributed by Synthes (USA).
Device Description
The Proximal Humerus Scaffold Fixation System (PHSFS) is intended for the repair of proximal humeral fractures. The system consists of a titanium plate, posts, cross-pegs, cortical screws, 1.5 mm K-Wires, manual surgical instruments, alignment fixture and a custom sterilization container.
Intended Use
The Proximal Humerus Scaffold Fixation System (PHSFS) is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.
Summary of Technological Characteristics
A 15-point comparison of technological characteristics and a 4-point comparison of performance characteristics of the TOBY Orthopaedics Proximal Humerus Scaffold Fixation System (PHSFS) and the predicate device were performed. The devices were found to be substantially equivalent.
1
Summary of Performance Data
The TOBY Orthopaedics Proximal Humerus Scaffold Fixation System (PHSFS) complies with the requirements of listed FDA Recognized Consensus Standards.
- ASTM F136-02a, Standard Specification for Wrought Titanium-6 Alumi-num-4 . Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401))
- ASTM F899-07, Standard Specification for Stainless Steel for Surgical In-. struments
The TOBY Orthopaedics Proximal Humerus Scaffold Fixation System (PHSFS) is substantially equivalent to Synthes LCP Proximal Humerus Plate that is legally marketed and distributed by Synthes (USA) This has been demonstrated through a 15-point technological comparison of features and a multi-parameter comparison of mechanical performance.
The implantable and tissue contact materials used to fabricate the Proximal Humerus Scaffold Fixation System (PHSFS) and Instruments have a long history of safe usage in medical devices. Because the TOBY Orthopaedics Proximal Humerus Scaffold Fixation System (PHSFS)s meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white.
DEC 1 9 2008
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TOBY Orthopaedics, LLC % Mr. Al Weisenborn 3773 Matheson Avenue Miami, Florida 33133
Re: K081608
Trade/Device Name: Proximal Humerus Scaffold Fixation System (PHSFS) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: September 25, 2008 Received: November 28, 2008
Dear Mr. Weisenborn:
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.
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Page 2 - Mr. Al Weisenborn
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark H. Millenson
Mark N. Melkerson 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 | ||
|---|---|---|
| Page 1 of 1 | ||
| 510(k) Number (if known): | K081608 | |
| Device Name: | Proximal Humerus Scaffold Fixation System (PHSFS) | |
| Indications for Use: |
The Proximal Humerus Scaffold Fixation System (PHSFS) is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.
| Prescription Use X
(Per 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) |
| -------------------------------------------------- | -------- | ------------------------------------------------ |
|---|
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K081608 |
|---|---|
| --------------- | --------- |
TOBY Orthopaedics
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