K Number
K041288
Device Name
MODIFICATION TO SMARTPIN
Date Cleared
2004-06-10

(28 days)

Product Code
Regulation Number
888.3040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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. 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.
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).
More Information

No
The device description focuses solely on the material composition, dimensions, and shape of a physical pin used for bone fixation. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.

Yes
The SmartPin® is indicated for the fixation of fractured non-load bearing bones, osteotomies, and arthrodeses, which is a therapeutic intervention.

No.
Explanation: The SmartPin® is indicated for fixation of bone fragments, osteotomies, and arthrodeses, which is a therapeutic function, not a diagnostic one. It is a physical medical device (pin), not a tool for identifying or characterizing a medical condition.

No

The device description explicitly states it is composed of a poly-96L/4D-lactide copolymer and describes physical characteristics like shape, lengths, and diameters, indicating it is a physical implantable device, not software.

Based on the provided text, the SmartPin® device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes the device as being used for the fixation of bone fragments during surgical procedures (fractures, osteotomies, arthrodeses). This is a direct medical intervention on the body.
  • Device Description: The device is described as a physical implant (pins) made of a copolymer, with specific dimensions. This is consistent with a surgical implant, not a diagnostic test performed on samples outside the body.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.

IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. The SmartPin® is used in vivo (inside the body) as a surgical implant.

N/A

Intended Use / Indications for 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.

Product codes

HTY

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

non-load bearing bones

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K010983, K003659, K890902, K993074, K031981

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.

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),
    1. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) SmartPin® PDX (the previous PLGA Pin) (K003659),
    1. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) Biofix SR-PGA Pin (K890902).
    1. 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