(36 days)
Synthes External Fixation Devices
Not Found
No
The document describes mechanical components for external fixation and mentions mechanical testing, with no indication of software, image processing, or AI/ML capabilities.
Yes
The device is intended for use in constructing an external fixation frame for treating various types of fractures, which falls under the definition of a therapeutic intervention.
No
The device is an external fixation system used for treating various fracture types by stabilizing bones; it does not perform diagnosis.
No
The device description explicitly states it consists of "various clamps, rods, tubes, bars and rings," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are used for the construction of an external fixation frame to treat various fracture types. This is a surgical intervention performed directly on the patient's body.
- Device Description: The device description lists components like clamps, rods, tubes, bars, and rings used to build a physical frame. These are mechanical devices for external support and stabilization.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on or in the body) for structural support and stabilization.
N/A
Intended Use / Indications for Use
Synthes External Fixation Devices are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.
LARGE/HYBRID
Provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for:
- . Stabilization of soft tissues and fractures
- Poyltrauma/multiple orthopedic trauma .
- Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic . fractures
- Arthrodeses and osteotomies with soft tissue problems; failures of total joints .
- Neutralization of fractures stabilized with limited internal fixation .
- Non-unions/septic non-unions .
- . Intra-operative reductions/stabilization tool to assist with indirect reduction
- Unilateral rectilinear bone segment transport or leg lengthening .
- Hybrid components are designed for fixation of complex proximal and distal tibia fractures, . particularly those involving the joint, when soft tissue injuries preclude open reduction and internal fixation, or the fracture pattern does not allow placement of Schanz screws for construction of a standard external fixation frame
MEDIUM
Indicated for construction of an external fixation frame for the treatment of pediatric and adult fractures.
SMALL
Stabilizes and provides treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle. Specifically, the components can be used for:
- Preliminary fixation before ORIF .
- Unstable fractures of the distal radius (both intra- and extra-articular) .
- Open and/or comminuted bilateral fractures .
- Fractures in combination with extensive soft tissue injury, bone loss, and vascular and/or . neural involvement
- Fracture dislocations .
- Failed closed reduction with casting resulting in secondary deformity (radial shortening and . angulations)
- . Pediatric open fractures with bone loss and osteotomies
MINI
Stabilizes and provides treatment for fractures of the hand and foot. Specifically, the components can be used for:
- Comminuted fractures of phalanges and metacarpals .
- Displaced intra-articular fractures
- Segmental bone loss
- Open fractures that do not allow stable internal fixation
- Fractures with associated complex soft tissue injuries
- Tumor resections
Product codes
KTT
Device Description
Synthes Reprocessed External Fixation Devices consist of various clamps, rods, tubes, bars and rings that are used to construct an external fixation frame. These devices are for single use only, and have been returned to Synthes for reprocessing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bone, pelvic, hand, wrist, forearm, foot, ankle.
Indicated Patient Age Range
Pediatric and adult.
Intended User / Care Setting
Prescription Use (Per 21 CFR 801.109)
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
Mechanical testing demonstrates that Synthes Reprocessed External Fixation Devices were shown to be equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Synthes External Fixation Devices
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.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. There is a horizontal line underneath the word. The logo and word are likely part of a company logo.
3.0
NOV - 5 2003
| 510(k) Summary | Page | 1 | of | 1 | |
|---|---|---|---|---|---|
| Sponsor: | Synthes (USA) | ||||
| 1690 Russell Road | |||||
| Paoli, PA 19301 | |||||
| (610) 647-9700 | K033158 | ||||
| Device Name: | Synthes Reprocessed External Fixation Devices | ||||
| Classification: | Class II, 21 CFR §888.3030 - Single/multiple component bone | ||||
| fixation appliances and accessories. | |||||
| Predicate Devices: | Synthes External Fixation Devices | ||||
| Device Description: | Synthes Reprocessed External Fixation Devices consist of various | ||||
| clamps, rods, tubes, bars and rings that are used to construct an | |||||
| external fixation frame. These devices are for single use only, and | |||||
| have been returned to Synthes for reprocessing. | |||||
| Intended Use: | Synthes External Fixation Devices are intended for use in the | ||||
| construction of an external fixation frame for treatment of various | |||||
| fracture types that require external fixation. | |||||
| Substantial | |||||
| Equivalence: | Mechanical testing demonstrates that Synthes Reprocessed | ||||
| External Fixation Devices were shown to be equivalent to the | |||||
| predicate device. |
0000000
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 stylized image of an eagle with three lines representing its wings and body. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 2003
Ms. Angela J. Silvestri Manager, Regulatory Affairs Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
Re: K033158
Trade/Device Name: Synthes (USA) Reprocessed External Fixation Devices Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: September 29, 2003 Received: September 30, 2003
Dear Ms. Silvestri:
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 -
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 (301) 594-4659. 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.
O Mark N. Milberson
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
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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line is present under the word "SYNTHES". The letter "S" has a registered trademark symbol next to it.
2.0 Indications for Use Statement
Page
510(k) Number (if known):
Device Name:
Synthes (USA) Reprocessed External Fixation Devices
INDICATIONS: Synthes External Fixation Devices are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.
LARGE/HYBRID
Provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for:
- . Stabilization of soft tissues and fractures
- Poyltrauma/multiple orthopedic trauma .
- Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic . fractures
- Arthrodeses and osteotomies with soft tissue problems; failures of total joints .
- Neutralization of fractures stabilized with limited internal fixation .
- Non-unions/septic non-unions .
- . Intra-operative reductions/stabilization tool to assist with indirect reduction
- Unilateral rectilinear bone segment transport or leg lengthening .
- Hybrid components are designed for fixation of complex proximal and distal tibia fractures, . particularly those involving the joint, when soft tissue injuries preclude open reduction and internal fixation, or the fracture pattern does not allow placement of Schanz screws for construction of a standard external fixation frame
MEDIUM
Indicated for construction of an external fixation frame for the treatment of pediatric and adult fractures.
(Indications are continued on the next page)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR Over-the-Counter Use
4
Image /page/4/Picture/0 description: The image shows the Synthes logo. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. There is a registered trademark symbol next to the "S" at the end of the word "SYNTHES". A horizontal line is present under the logo.
2.0 Indications for Use Statement (continued)
Page 2
510(k) Number (if known):
Device Name:
Synthes (USA) Reprocessed External Fixation Devices
(Indications continued from previous page)
SMALL
Stabilizes and provides treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle. Specifically, the components can be used for:
- Preliminary fixation before ORIF .
- Unstable fractures of the distal radius (both intra- and extra-articular) .
- Open and/or comminuted bilateral fractures .
- Fractures in combination with extensive soft tissue injury, bone loss, and vascular and/or . neural involvement
- Fracture dislocations .
- Failed closed reduction with casting resulting in secondary deformity (radial shortening and . angulations)
- . Pediatric open fractures with bone loss and osteotomies
MINI
Stabilizes and provides treatment for fractures of the hand and foot. Specifically, the components can be used for:
- Comminuted fractures of phalanges and metacarpals .
- Displaced intra-articular fractures
- Segmental bone loss
- Open fractures that do not allow stable internal fixation
- Fractures with associated complex soft tissue injuries
- Tumor resections
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use
CONFIDENTIAL
00005