← Product Code [JEY](/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY) · K020087 # SYNTHES CRANIAL PLATES (K020087) _Synthes (Usa) · JEY · Feb 20, 2002 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K020087 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [JEY](/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY.md) - **Decision Date:** Feb 20, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.4760 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use The Synthes Cranial Plates are intended for use in selective trauma of the craniofacial skeleton; craniofacial surgery; reconstructive surgery; and selective orthognathic surgery of the maxilla and chin. ## Device Story Synthes Cranial Plates are titanium plates designed for fixation in craniofacial procedures. Used by surgeons in clinical settings to stabilize bone segments following trauma or during reconstructive and orthognathic surgeries. Plates are provided in various shapes to accommodate anatomical requirements of the maxilla and chin. Device functions as a mechanical fixation system to support bone healing and structural integrity. Clinical benefit includes stabilization of the craniofacial skeleton. ## Technological Characteristics Titanium bone plates; various shapes for craniofacial fixation; Class II device (872.4760, 882.5250). ## Regulatory Identification A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments. ## 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}------------------------------------------------ # FEB 2 0 2002 #### Summary of Safety and Effectiveness Information 3. Ko20087 Sponsor Company Contact Name of the Device Device Classification(s) Substantial Equivalence Device Description Indications Material Synthes (USA) 1690 Russell Road Paoli, PA 19301 Matthew M. Hull (610) 647-9700 ext. 7191 Synthes Cranial Plates Class II, §872.4760 - Plate, Fixation, Bone Class II, §882.5250 - Burr Hole Cover Documentation was provided which demonstrated the Synthes Documentation was provided which equivalent to other legally marketed devices. The Synthes Cranial Plates are titanium plates in a variety of shapes The Synanes Crand for various cranio-facial procedures. The Synthes Cranial Plates are intended for use in selective trauma of The ByInthos Craniofacial skeleton; craniofacial surgery; the initiface and craineral in is selective orthognathic surgery of the maxilla and chin Titanium Synthes(USA) Synthes Cranial Plates 510(k) CONFIDENTIAL 000005 {1}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. ### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 0 2002 Mr. Matthew M. Hull Senior Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301 Re: K020087 Trade/Device Name: Synthes Cranial Plates Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Codes: JEY and GXR Dated: January 07, 2002 Received: January 10, 2002 Dear Mr. Hull: We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Secuon 710(x) personalially equivalent (for the referenced above and have attermined to legally marketed predicate devices marketed in indications for use stated in the enclosure , to legally marketed in the enclose for us indications for use stated in the cholosator , to he enactment date of the Medical Device interstate commerce prior to reay 20, 1770, and enified in accordance with the provisions of Amendments, or to devices that have been reclassified in accordance approvel of a Amendments, or to devices that nave been rocal require approval of a premarket the Federal Food, Drug, and Cosmetic Act (Act) that do not requires, subject to the general the Federal Food, Drug, and Cosment / col (recore, market the device, subject to the general approval application (PMA). You may, therefore, market the Act include approval application (1 MA). "Tou may) and controls provisions of the Act include controls provisions or the Act. The genting of devices, good manufacturing practice, requirements for annical rogginst misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III) If your device is classified (sec above) incolors. Existing major regulations affecting (PMA), it may be subject to such additional controls. Time 21, Rests 800 to 898 (PMA), it may be subject to Such additional concern Regulations, Title 21, Parts 800 to 898. In your device can be found in the Code of Federal Regulations, Title Register i your device can be found in the Code of Pecelar regionerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualles of a substance of the requirements mean that FDA has made a determination that your device complies with organizes mean that FDA has made a decemination untily of the Federal agencies. of the Act or any Federal statutes and regulations administered by other Federal agencies. {2}------------------------------------------------ ## Page 2 - Mr. Matthew M. Hull You must comply with all the Act's requirements, including, but not limited to: registration ing and the many of the line (0) - GED Port Roll); good manufacturing practice You must comply with all the Act s'requirence.se increating oud manufacturing practice and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807); labellity (21 CF PC PC PC Part 820); and if requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality systems (QB) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section This letter will allow you to begin marketing your covistantial equivalence of your device to 510(k) premarket notification. The FDA finding of sourcevice and thus, 510(k) premarket notification. The PDA finantig or casestion for your device and thus, a legally mur device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 ) and the If you desire specific advice for your device in vitro diagnostic devices), please contact the and additionally 21 CFR Part 809.10 for in valid the donestions on the promotion and Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Office of Compliance at (301) 594-4015. "Italifone of Compliance at (301) 594-4639. advertising of your device, please contact the Office has been programs to premarket advertising of your device, picase consisted, "Misbranding by reference to premarket. Also, please note the regulation entitled, "Internation on your responsibilities under notification" (21CFR Part 807.97). Other general information on your responsibilities notification" (21CFR Part 807.97). Unier general Manufacturers, International and the Act may be obtained from the Division of Only 638-2041 or (301) 443-6597 or at its Consumer Assistance at its toll-free number (80) was an html Consumer Assistance at its ton nov fodrh/dsma/dsmamain.html Sincerely yours, Patrea Cinciniffe Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### Indications for Use Statement 2. ## 510(k) Number (if known): Device Name: Indications for Use: ## Synthes Cranial Plates The Synthes Cranial Plates are intended for use in I he Synthes Crainal I lawdface and craniofacial is selective trauma of the mirala"; reconstructive skeleton; cramoracial surgery, orthognathic surgery of the maxilla and chin. 020087 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) CONFIDENTIAL Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use_ 000004 | Division Sign-Off | Phamida D. Sood for Swann H | |-------------------|-----------------------------| | | Dental Infection Control, | | | ral Devices | | | KC20087 | #### Synthes(USA) Synthes Cranial Plates 510(k) --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K020087](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K020087) **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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