← Product Code [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS) · K083025 # SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM (K083025) _Synthes (Usa) · HRS · Jan 14, 2009 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K083025 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS.md) - **Decision Date:** Jan 14, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Synthes 4.5 mm VA-LCP Curved Condylar System is intended for buttressing multi-fragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, and non-unions and malunions. ## Device Story The Synthes 4.5 mm VA-LCP Curved Condylar System consists of metallic bone plates and screws designed for internal fixation of distal femur fractures. The system utilizes a variable angle locking construct, allowing screws to be locked at trajectories diverging from the central axis of the plate hole. This provides enhanced fracture fixation flexibility. The device is intended for use by surgeons in clinical settings to stabilize bone fragments. It functions as a mechanical buttressing system to support healing in complex fracture patterns. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Metallic bone fixation system consisting of plates and screws. Features variable angle locking mechanism allowing screw trajectory adjustment. Class II device under 21 CFR 888.3030. ## 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 - Synthes 4.5 mm Curved Broad LCP Plates - Synthes Locking Condylar Plates - Synthes Condylar Buttress Plate - DCP - Synthes 4.5 mm Broad DCP Plates ## 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 a stylized font. To the left of the word is a circular logo with a design inside. A registered trademark symbol is present to the right of the word. 一 | 3.0 | 510(k) Summary | K083025 | Page 1 of 1 | |-----|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | | Sponsor: | Synthes (USA)
1301 Goshen Parkway
West Chester, PA 19380
(610) 719-6940 | | | | Contact: | Sheri L. Musgnung
Synthes (USA)
1301 Goshen Parkway
West Chester, PA 19380
(610) 719-6940
FAX (610) 484-356-9682 | JAN 14.2009 | | | Device Name: | Synthes 4.5 mm VA-LCP Curved Condylar System | | | | Classification; | Class II, §888.3030 - Single/multiple component metallic bone
fixation appliances and accessories | | | | Predicate Device: | Synthes 4.5 mm Curved Broad LCP Plates
Synthes Locking Condylar Plates
Synthes Condylar Buttress Plate - DCP
Synthes 4.5 mm Broad DCP Plates | | | | Device Description: | The Synthes 4.5 mm VA-LCP Curved Condylar System consists of
plates and screws that offer a screw to plate variable angle locking
construt. The 4.5 mm VA-LCP Curved Condylar System enhances
fracture fixation by providing the flexibility to lock screws in
trajectories that can diverge from the central axis of the plate hole. | | | | Intended Use: | The Synthes 4.5 mm VA-LCP Curved Condylar System is intended
for buttressing multi-fragmentary distal femur fractures including:
supracondylar, intra-articular and extra-articular condylar fractures,
periprosthetic fractures, fractures in normal or osteopenic bone,
and non-unions and malunions. | | | | Substantial
Equivalence: | Information presented supports substantial equivalence. | | - - - - - - 1. September 19. . 000005 - - - ------------------------------------------------------------------------------------------------------------------------------------------------------------------------ : .............................................................................................................................................................................. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ : {1}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white. ## Public Health Service · JAN 1 4 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Synthes® (USA) % Ms. Sheri L. Musgnung Regulatory Affairs Manager 1301 Goshen Parkway West Chester. Pennsylvania 19380 Re: K083025 Trade/Device Name: Synthes® 4.5mm VA-LCP Curved Condylar System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, JDP, HWC Dated: December 10, 2008 Received: December 11, 2008 Dear Ms. Musgnung: 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 (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 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. Sheri L. Musgnung 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 the reporting 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 Mulkerson Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ SYNTHES" Indications for Use 5 HD(k) Number (if known): K083025 Device Name: 2.0 Synthes 4.5 mm VA-LCP Carved Condylar System Indications for Use: The Synthes 4.5 mm VA-1.CP Curved Condyler System is intended for buttressing multi-fragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in hormal or osteopenic bone, and non-unions and malunions. Preseription 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) ![.](null) **(Division Sign-Off)** Division of General, Restorative, and Neurological Devices 510(k) Number_ ﺖ 000004 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K083025](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K083025) **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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