← Product Code [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY) · K041288 # MODIFICATION TO SMARTPIN (K041288) _Linvatec Biomaterials, Inc. · HTY · Jun 10, 2004 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K041288 ## Device Facts - **Applicant:** Linvatec Biomaterials, Inc. - **Product Code:** [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY.md) - **Decision Date:** Jun 10, 2004 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use SmartPin® is indicated for fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments in the presence of appropriate immobilization. ## Device Story SmartPin is a bioabsorbable bone fixation pin composed of poly-96L/4D-lactide copolymer. It is a tapered, smooth pin available in lengths of 10-70mm and diameters of 1.1-4.5mm. The device is used by surgeons for internal fixation of non-load bearing bone fragments, osteotomies, and arthrodeses. It functions as a mechanical fastener to hold bone fragments in place during the healing process. The device is intended for use in clinical settings where appropriate immobilization can be maintained. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on design, material, and intended use similarities to previously cleared predicate devices. ## Technological Characteristics Material: poly-96L/4D-lactide copolymer. Form factor: tapered, smooth pins (10-70mm length; 1.1-4.5mm diameter). Principle: bioabsorbable mechanical bone fixation. Sterilization: same processes as predicate devices. ## Regulatory Identification A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - SmartPin® (the previous PLLA Pin) ([K010983](/device/K010983.md)) - SmartPin® PDX (the previous PLGA Pin) ([K003659](/device/K003659.md)) - Biofix SR-PGA Pin ([K890902](/device/K890902.md)) - SmartNail® ([K993074](/device/K993074.md), [K031981](/device/K031981.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}------------------------------------------------ K 041288 pge 1/2 JUN 1 0 2004 # 510(k) Summary Linvatec Biomaterials SmartPin ## Submitter's Name, Address, Telephone Number, and Contact Person Linvatec Biomaterials Ltd. Tuija Annala Director, Quality and Regulatory Affairs P.O.Box 3 FIN-33721 Tampere Finland, Europe 358-3-316 5600 Phone: 358-3-316 5629 Facsimile: March 9, 2004 Date prepared: #### Name of the device: - Trade or Proprietary Name: SmartPin A. - Common Name: B. ## Bioabsorbable bone fixation pin - Classification Name: C. Bone Fixation Pin class II, HTY Device Product Code: D. ### Predicate Device: - 1. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) SmartPin® (the previous PLLA Pin) (K010983), - 2. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) SmartPin® PDX (the previous PLGA Pin) (K003659), - 3. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) Biofix SR-PGA Pin (K890902). - 4. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) SmartNail® (K993074, K031981) #### Intended Use: SmartPin® is indicated for fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments in the presence of appropriate immobilization. {1}------------------------------------------------ Ko41288 pg2½ ### Device Description: The device description of SmartPin® is as follows: - Composed of poly-96L/4D-lactide copolymer - - Tapered, smooth pins - - Lengths 10 70mm - - Diameters 1.1, 1.5, 2.0, 3.2 and 4.5 mm - The dimensions and shape are completely identical with Linvatec Biomaterials The unnersholis and brin) (K010983), SmartPin® PDX (the previous PLGA Pin) (K003659) and Biofix SR-PGA Pin (K890902). ### Substantial Equivalence: SmartPin® made of poly-96L/4D-lactide copolymer owns the following similarities to cleared devices SmartPin® (the previous PLLA Pin) (K010983), SmartPin® PDX (the previous PLGA Pin) (K003659) and Biofix SR-PGA Pin (K890902): - has the same or similar indicated use - - use the same operating principle - - incorporate the same basic design - - is manufactured by same machinery - - is packaged and sterilized using the same materials and processes - In summary, SmartPin® described in this notification is, in our opinion, substantially equivalent to the predicate device. {2}------------------------------------------------ Image /page/2/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 stylized lines. Public Health Service JUN 1 0 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Tuija Annala Director, Quality and Regulatory Affairs Linvatec Biomaterials Ltd. P.O. Box 3 Hermiankatu 6-8 L FIN 33721 Tampere, Finland Re: K041288 Trade/Device Name: SmartPin® Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: March 15, 2004 Received: May 13, 2004 Dear Ms. Annala: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section >10(x) premainter networked (for the indications referenced above and have determined the device is substantial in interstate referenced above and nave decemblicated the devices marketed in interstate for use stated in the encrosule) to regally manator promotical Device Amendments, or to commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the characters and other cransmission of the Federal Food, Drug. devices that have been recarsined in accordance was a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarket approval as . T and Cosment Act (Act) that do not require approvide controls provisions of the Act. The You may, therefore, market the device, beloject to the one of registration, listing of general controls provisions of the Act include requirements for annual registrations on general controls provisions of the free mericans and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) not existing major regulations affecting your device can may be subject to such additional controls. The Color Roge 4 - Roge of Cold may be subject to such additional controlis. Extreme major to 898. In addition, FDA may be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Pederal Regeraline your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that TDA's issuates of a basediants with other requirements of the Act that FDA has made a determination that your device complies with other mat that FDA has made a decermination that your and be other Federal agencies. You must as and listing or any Federal statutes and regulations daministered of registration and listing (21 comply with all the Act's requirements, including, but not limited to set comply with and the Act s requirements, moradiants practice requirements as set CFR Part 807); labeling (21 CFR Part 801); good manufacturing plactic she electron CFK Part 807); labeling (21 CFR Part 007); good manatt 820); and if applicable, the electronic forth in the quality systems (QS) regulation (21 CFR 100); 11 CFR 1000 1050 forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050. Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000 {3}------------------------------------------------ Page 2 - Ms. Tuija Annala This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin narksmig your antial equivalence of your device to a legally premarket notification. The FDA midnig of substantial equivaliation for your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please r the regulation and 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11, 11 If you desire specific advice for your device of (301) 594-4639. Also, please note the regulation entitled, contact the Office of Compliance at (301) 594-4639. Also, please n contact the Office of Compliance at (2017) 59 - 187.97 Part 807.97) you may obtain. "Misbranding by reference to premarket notification" (2014) - 1) voltained from the "Whisorallumg by refective to premation in the Act may be obtained from the state toll from the Other general information on your responsional 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, Mark A. Milken 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 {4}------------------------------------------------ ### INDICATIONS FOR USE 510(K) Number (if known): K041288 Device Name: SmartPin® ### Indications for Use: SmartPin® is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical Dearing 'oches, 'osteochonies and cancellous/non-load bearing fragments. SmartPin® is not intended for use in and is contraindicated for: 1) Fractures and Sthart mis is not intended for assess cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) treatment of which patient co operation callier see effect of SmartPin® upon the healing of growth plate has not been tested clinically. (Please do not write below this line - continue on another page is needed) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use_ OR Mark N Milken Division of General, Restorative. and Neurological Devices **510(k) Number** K011288 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K041288](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K041288) **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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