← Product Code [LXT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT) · K063832 # SYNTHES (USA) ELBOW HINGE FIXATOR (K063832) _Synthes (Usa) · LXT · Mar 7, 2007 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT/K063832 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [LXT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT.md) - **Decision Date:** Mar 7, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic, Pediatric ## Intended Use The Synthes Elbow Hinge Fixator is intended for supplementary treatment of complex, unstable elbow injuries when early functional stress must be limited due to persistent ligament instability. The indications for guided joint bridging with external fixators are: -Delayed treatment of dislocated and stiff elbows -Chronic, persistent joint instability -Acute joint instability after complex ligament injuries -Unstable elbow fractures -Additional stabilization of post-operative unstable internal fixation The Elbow Hinge Fixator is compatible with the components of the Synthes Large External Fixator for adults, and with the components of the Synthes Medium External Fixator for children and small stature adults. ## Device Story External fixation device for elbow stabilization; consists of two rods connected by a riveted hinge joint. Input: mechanical alignment of elbow joint by surgeon. Operation: provides guided joint bridging and hinge-like movement to support healing while limiting functional stress. Output: physical stabilization of the elbow joint. Used in clinical settings by orthopedic surgeons. Benefits: allows controlled range of motion (avg 270 degrees) for complex, unstable injuries; prevents further displacement; supports post-operative recovery. ## Clinical Evidence Bench testing only. ## Technological Characteristics Materials: carbon fiber reinforced PEEK rods, stainless steel joint. Dimensions: 180mm length. Range of motion: 270 degrees. Connectivity: None. Energy source: None (mechanical). Sterilization: Not specified. ## Regulatory 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. ## Predicate Devices - Stryker-Dynamic Joint Distractor II ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 below the word. The registered trademark symbol is to the right of the word. K063832 | 3.0 | 510(k) Summary | Page 1 of 1 | |-----|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Sponsor: | Synthes (USA)
1301 Goshen Parkway
West Chester, PA 19380
(610) 719-5000
MAR 07 2007 | | | Contact: | Jennifer Perks
Synthes (USA)
1301 Goshen Parkway
West Chester, PA 19380
610-719-6941 | | | Device Name: | Synthes (USA) Elbow Hinge Fixator | | | Classification: | The classification of the Synthes Elbow Hinge Fixator as per 21 of
the Code of Federal Regulations, Section 888.3030 –
Single/Multiple Component metallic bone fixation appliances and
accessories | | | Predicate Device: | Stryker-Dynamic Joint Distractor II | | | Device Description: | The Synthes Elbow Hinge Fixator consists of two rods, which are
interconnected through a riveted joint, allowing a hinge-like
movement. The rods are made of carbon fiber reinforced PEEK,
and the joint is made of stainless steel. The overall length of the
device is 180mm and the achievable range of motion averages 270
degrees. | | | Intended Use: | The Synthes Elbow Hinge Fixator is intended for supplementary
treatment of complex, unstable elbow injuries when early
functional stress must be limited due to persistent ligament
instability. | | | | The indications for guided joint bridging with external fixators are:
-Delayed treatment of dislocated and stiff elbows
-Chronic, persistent joint instability
-Acute joint instability after complex ligament injuries
-Unstable elbow fractures
-Additional stabilization of post-operative unstable internal fixation | | | | The Elbow Hinge Fixator is compatible with the components of the
Synthes Large External Fixator for adults, and with the components
of the Synthes Medium External Fixator for children and small
stature adults. | | | Substantial
Equivalence: | Documentation is provided which demonstrates the Synthes Elbow
Hinge Fixator to be substantially equivalent to other legally
marketed devices. | . . , . {1}------------------------------------------------ Public Health Service Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Synthes (USA) % Ms. Jennifer Perks Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, PA 19380 MAR 0 7 2007 Re: K063832 Trade/Device Name: Elbow Hinge Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: LXT Dated: December 22, 2006 Received: December 26, 2006 Dear Ms. Perks: 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 - Ms. Jennifer Perks 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Mark A. Millerson Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 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 underneath the word "SYNTHES" and the logo. A registered trademark symbol is to the right of the word. Indications for Use 510(k) Number (if known): Device Name: Synthes (USA) Elbow Hinge Fixator Indications for Use: The Synthes Elbow Hinge Fixator is intended for supplementary treatment of complex, unstable elbow injuries when early functional stress must be limited due to persistent ligament instability. The indications for guided joint bridging with external fixators are: -Delayed treatment of dislocated and stiff elbows -Chronic, persistent joint instability -Acute joint instability after complex ligament injuries -Unstable elbow fractures -Additional stabilization of post-operative unstable internal fixation The Elbow Hinge Fixator is compatible with the components of the Synthes Large External Fixator for adults, and with the components of the Synthes Medium External Fixator for children and small stature adults. X Prescription Use (Per 21 CFR 801.109) 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) (Division Sign-Off) Division of General Restorative. Page of Neurological Devices K063832 Synthes (USA) ELBOW HINGE FIXATOR - 4 - CONFIDENTIAL 1 2.0 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT/K063832](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT/K063832) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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