← Product Code LZJ · K132496 # ARTHROSURFACE TOEMOTION (K132496) _Arthrosurface, Inc. · LZJ · Feb 26, 2014 · OR · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K132496 ## Device Facts - **Applicant:** Arthrosurface, Inc. - **Product Code:** LZJ - **Decision Date:** Feb 26, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** OR - **Attributes:** Therapeutic ## Intended Use The Arthrosurface Total Toe Resurfacing System is a two-piece implant that is intended to be used as prosthesis for the metatarso-phalangeal joint (MTP). The device is intended for cemented use only. Indications for use include: Painful degenerative metatarso-phalangeal joint change . . Hallus rigidus stage 3 and 4 . . Hallux valgus and hallux rigidus . Hallux limitus with painful arthrofibrosis . Revisions after moderate proximal phalanx resection . ## Device Story Two-piece orthopedic implant system for metatarso-phalangeal (MTP) joint resurfacing; consists of metatarsal and proximal phalanx components. Metatarsal component features CoCrMo articular surface with CP Ti plasma spray and Ti-6Al-4V ELI fixation base; proximal phalanx component features Ti-6Al-4V ELI fixation base with UHMWPE inlay. Components mate via taper interlock for cemented fixation. Used by orthopedic surgeons in clinical settings to replace MTP joint while preserving sesamoid complex. Provides stable, stress-bearing joint interface to alleviate pain and restore function in patients with degenerative joint disease or deformity. ## Clinical Evidence No clinical data. Safety and effectiveness supported by non-clinical bench testing: wear testing, contact area/stress analysis, assembly/disassembly testing, bending moment/flexural load testing, delivery tool strength testing, and finite element analysis. ## Technological Characteristics Materials: CoCrMo (ASTM F799), CP Ti Plasma Spray (ASTM F1580), Ti-6Al-4V ELI (ASTM F136), UHMWPE (ASTM F648). Design: Two-piece semi-constrained metal/polymer prosthesis. Fixation: Cemented, taper interlock. Sterilization: Not specified. ## Predicate Devices - Ascension MOVEMENT Great Toe System ([K102549](/device/K102549.md)) - Merete ToeMobile Anatomical Great Toe Resurfacing System ([K072251](/device/K072251.md)) ## 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 6 2014 #### Section 5 510(k) Summary | 510(k) Owner: | Arthrosurface, Inc.
28 Forge Parkway
Franklin, MA 02038
Tel: 508.520.3003
Fax: 508.528.4604 | |-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | Contact: | Dawn Wilson
VP, Quality & Regulatory | | Date of Preparation: | February 21, 2014 | | Trade Name: | Arthrosurface® ToeMotion™ | | Common Name: | Arthrosurface® Total Toe - Proximal Phalanx Implant | | Device: | Prosthesis, Toe (metatarso-phalangeal), Joint,
Metal/polymer, Semi-constrained | | Classification Regulation:
Device Class:
Review Panel:
Product Code: | Unclassified (Reason: Pre-Amendment)
Unclassified
Orthopedic
LZJ | ### Device Intended Use The Arthrosurface Total Toe Resurfacing System is a two-piece implant that is intended to be used as prosthesis for the metatarso-phalangeal joint (MTP). The device is intended for cemented use only. Indications for use include: - Painful degenerative metatarso-phalangeal joint change . - . Hallus rigidus stage 3 and 4 - . Hallux valgus and hallux rigidus - Hallux limitus with painful arthrofibrosis . - Revisions after moderate proximal phalanx resection . ## Device Description The Arthrosurface® Total Toe System consists of a metatarsal component and a phalangeal component designed for resurfacing the 15 metatarsal head and the base of the proximal phalanx. These two implants replace the metatarso-phalangeal joint by complete functional preservation of the joint and maintaining of the sesamoid complex. {1}------------------------------------------------ The Metatarsal Implant incorporates a CoCrMo articular resurfacing component per ASTM F799 with CP Ti Plasma Spray coating per ASTM F1580 and a Ti-6AI-4V ELI alloy fixation component per ASTM F136 that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface. The device is 15mm articular implant with a dorsal flange feature for additional implant coverage in the dorsal plane. The Proximal Phalanx Implant consists of a Ti-6Al-4V ELI alloy fixation component per ASTM F136 with CP Ti Plasma Spray coating per ASTM F1580 and an Ultra High Molecular Weight Polyethylene inlay per ASTM F648. # Substantial Equivalency: The intended use, materials, design features and application of the Proposed Device are substantially equivalent to the following previously cleared and commercially marketed devices: - Ascension MOVEMENT Great Toe System K102549 � - . Merete ToeMobile Anatomical Great Toe Resurfacing System K072251 The fundamental scientific technology of the proposed device has not changed relative to the predicate devices. - Total arthroplasty for the MTP joint . - Same indications for use . - Similar device designs o - Same implant materials . In support of this submission, the following non-clinical tests have been performed on the Subject Device: - Wear testing . - Contact area / Contact stress . - Assembly / Disassembly of Articular and Fixation components . - Bending moment / Flexural load . - Strength of delivery tool . - . Finite Element Analysis The results have demonstrated the safety and effectiveness of the Arthrosurface® Total Toe - Proximal Phalanx Implant along with substantial equivalence to the predicate devices. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and centered. Image /page/2/Picture/1 description: The image is a simple black and white image. The image is mostly white, with a few small black dots scattered around. The dots are concentrated in the upper right and lower right corners of the image. Public Health Service Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 26, 2014 Arthrosurface, Incorporated Ms. Dawn Wilson Vice President, Quality and Regulatory 28 Forge Parkway Franklin, Massachusetts 02038 Re: K132496 Trade/Device Name: Arthrosurface® Total Toe - Proximal Phalanx Implant Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LZJ Dated: January 24, 2014 Received: January 28, 2014 Dear Ms. Wilson: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 or any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {3}------------------------------------------------ Page 2 - Ms. Dawn Wilson 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### Indications for Use Statement Section 4 K132496 510(k) Number (if known): . Device Name: Arthrosurface® Total Toe - Proximal Phalanx Implant ### Indications for Use: The Arthrosurface Total Toe Resurfacing System is a two-piece implant that is intended to be used as prosthesis for the metatarso-phalangeal joint (MTP). The device is intended for cemented use only. Indications for use include: - Painful degenerative metatarso-phalangeal joint change ● - o Hallus rigidus stage 3 and 4 - Hallux valgus and hallux rigidus 0 - Hallux limitus with painful arthrofibrosis o - . Revisions after moderate proximal phalanx resection Prescription Use X (Part 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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 Image /page/4/Picture/16 description: The image shows the text "Casey L. Hanley, Ph.D." above a horizontal line, with the text "Division of Orthopedic Devices" below the line. The text is surrounded by a stylized FDA logo. The logo appears to be a stylized version of the letters FDA. 510(k) Page 15 --- **Source:** [https://fda.innolitics.com/device/K132496](https://fda.innolitics.com/device/K132496) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com