SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020

• K Number: K042295
• Device Name: SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
• Manufacturer: LINVATEC BIOMATERIALS, LTD.
• Date Cleared: 2004-09-16 ( 23 days)
• Product Code: HWC
• Regulation Number: 888.3040
• Type: Special
• Panel: Orthopedic
• Reference & Predicate Devices: K012001
• Predicate For: K050388

Intended Use

SmartScrew® II is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses of cancellous bone with the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and 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Device Description

SmartScrew® II is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses of cancellous bone with the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and 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AI/ML Overview

This 510(k) premarket notification for the SmartScrew II is a Special 510(k), meaning it is for a modification to a previously cleared device (the SmartScrew/NuGenFX Screw, K012001). As such, the submission focuses on demonstrating that the revised device is substantially equivalent to the predicate device, especially regarding the modification, rather than proving performance against novel acceptance criteria through extensive clinical studies like a de novo device might require.

Therefore, the provided document does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria in the way a new device would. Instead, the "study" is more accurately a comparison to the predicate device focusing on the impact of the design change.

Here's how to address your request based on the provided text, recognizing the nature of a Special 510(k):

Acceptance Criteria and Reported Device Performance

The acceptance criteria for a Special 510(k) revolve around demonstrating that the modifications do not negatively impact the safety and effectiveness of the device and that it remains substantially equivalent to the predicate. The performance is assessed by comparing the new design feature (screw head) against the predicate.

Acceptance Criteria Category	Criteria (Implicit from Special 510(k) context)	Reported Device Performance (as per submission)
Intended Use	The device maintains the same intended use as the predicate.	"the same indicated use"
Principles of Operation	The fundamental mechanism by which the device achieves its purpose remains unchanged.	"uses the same operating principle"
Basic Design of Thread	The screw thread design, crucial for fixation, is identical to the predicate.	"incorporates the same basic design of thread"
Basic Dimensions	Overall critical dimensions are maintained, except for the specific head modification.	"utilizes the same basic dimensions" (implying the functional dimensions outside the head modification are similar)
Manufacturing Process	The method of production remains consistent.	"is manufactured by machining"
Packaging & Sterilization	The safety and efficacy of these processes are unchanged.	"is packaged and sterilized using the same materials and processes"
Shelf Life	The stability and integrity of the device over time are not affected.	"has the same shelf life"
Effect on Torsion Properties	The new head design should not compromise the screw's ability to withstand torsional forces during insertion.	"The main purposes were smaller size of screw head and improvement of installation properties without scarifying torsion properties of the screw model." (This is a claim, and generally, for a special 510(k), bench testing data would be provided to support this, even if not detailed in the summary. The summary implies that testing demonstrated no negative impact on torsion properties, or perhaps an improvement in installation without loss of torsion.)
Material / Biocompatibility	Raw materials remain the same, ensuring continued biocompatibility.	"The revision of head design has no effect on... raw material"
Sterilization	Sterilization methods remain the same.	"The revision of head design has no effect on... sterilization"
Risk Assessment (Safety/Efficacy)	No new risks are introduced, and overall safety and effectiveness are maintained.	The entire submission aims to demonstrate this by showing substantial equivalence in all critical aspects. The FDA's clearance confirms this was deemed met.

Study Information (Based on Special 510(k) Context)

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Sample Size: Not explicitly stated. For a Special 510(k) focused on a design change like this, the "test set" would typically involve bench testing of the new screw head design and the predicate design for properties like torsional strength, insertion torque, and perhaps pull-out strength. The sample size for such bench tests would likely involve a statistically significant number of screws of each type, but this is not detailed in the summary.
   • Data Provenance: Not stated. Given the manufacturer is based in Finland, the testing would likely have been conducted in Europe or by contractors. It would be prospective bench testing designed specifically to compare the new and predicate designs.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • This is not applicable in the context of this 510(k). "Ground truth" established by experts (like radiologists for imaging devices) is relevant for diagnostic devices or those requiring subjective clinical assessment. For a mechanical fixation device undergoing a minor design change evaluated by substantial equivalence, "ground truth" is typically established through objective engineering tests (bench testing) and comparison against established performance criteria of the predicate. Engineers and biomechanical specialists would design and execute these tests.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods (like 2+1 for discordant expert reads) are used in studies involving human interpretation or clinical outcomes where subjectivity might exist. For objective engineering bench tests, results are typically quantitative and directly compared, not "adjudicated."

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This is a mechanical orthopedic fixation device, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic performance, particularly with AI assistance in image interpretation.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device does not involve an algorithm or AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this type of device, especially for a special 510(k), is primarily objective engineering and biomechanical data (e.g., torsional strength, insertion torque, material properties) derived from bench testing comparing the modified device to the predicate device and ensuring it meets its original performance specifications and does not introduce new risks.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device, so there is no "training set" in that sense. If referring to product development testing, materials were iterated and developed, but not as a "training set" for an algorithm.

8. How the ground truth for the training set was established:

   • Not applicable. See point 7.

Summary

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K042295
page 1/2

SEP 1 6 2004

510(k) Summary Linvatec Biomaterials SmartScrew II

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: Facsimile: 358-3-316 5629

Date prepared: May 26, 2004

Name of the device:

• A. Trade or Proprietary Name: SmartScrew II
• Common Name: B.

e. Smartscrew II
Dischargeable. Th

• C.
  Bioabsorbable, Threaded, Fixation Rod

HWC and MAI

Classification Name: Biodegradable fixation fastener, bone

• D. Device Product Code:

Predicate Devices:

Linvatec Biomaterials (the previous Bionx Implants Inc). SmartScrew™M (K012001)

The predicate device is the previously cleared Linvatec Biomaterials (the previous Bionx Implants) Ø 2.0mm fully threaded, solid NuGenFX Screw (K012001). Purpose of this special 510(k) premarket notification is introduction of the new revised head design for Ø 2.0mm fully threaded, solid screw model and introduction of new trade name, SmartScrew® II.

Originally the screw head design of Ø 2.0mm fully threaded, solid NuGenFX Screw (K012001) was designed as a cloverleaf head. Further development of head design for smaller outer diameter and easier insertion of Ø 2.0mm screw model continued and finally new head design with outer attachment of screw driver was finalized. The main purposes were smaller size of screw head and improvement of installation properties without scarifying torsion properties of the screw model.

The revision of head design has no effect on intended use, principles of operation, production methods, raw material or sterilization.

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pge 华2

The Ø 2.0mm fully threaded, solid SmartScrew® II has the following similarities to the cleared model Ø 2.0mm fully threaded, solid NuGenFX Screw (K012001):

• u has the same indicated use
• uses the same operating principle -
• incorporates the same basic design of thread -
• utilizes the same basic dimensions
• is manufactured by machining -
• is packaged and sterilized using the same materials and processes
• has the same shelf life -

In summary, the Ø 2.0mm fully threaded, solid SmartScrew® II is, in our opinion, substantially equivalent to the predicate device.

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, depicted with three stylized lines forming its body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2004

Ms. Tuija Annala Director, Quality and Regulatory Affairs Linvatec Biomaterials Ltd. P.O. Box 3 Hermiankatu 6-8 L FIN 33721 Tampere, Finland

Re: K042295

Trade/Device Name: SmartScrew® II Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 18, 2004 Received: August 24, 2004

Dear Ms. Annala:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Tuija Annala

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

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Indications for Use

510(k) Number (if known):

Ko42795

SmartScrew® II Device Name:

Indications For Use:

SmartScrew® II is generally intended for maintenance of alignment and fixation of SmartScrew® II is generally intended for manats within the condylar aspects of tractures, osteolomies, arthroucses of conce . of appropriate brace and/or Specifically, it is intended for phalangeal fusion and fracture, immobilization. metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal metacarpal fractures, olecranon fractures, radial head fractures, humeral condylar fractures ractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus.

SmartScrew® II is not intended for use in and is contraindicated for: 1) Fractures and SmartScrew® 11 1s not mended for about the hand and foot) and proximal femoral ostedtomies of contical oolic (cxcopt thereal fixation is otherwise contraindicated, e.g., Iractures. 2) Situations where interestient co-operation cannot be guaranteed (c.g. active of potential intection and which would not be appropriate for fixation with metallic screws. 4) Patients with suspected or known allergy to the implant material.

h 22 Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ No (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)

Miriam C. Provost

(Division Sign-Off) (Division DigDivision of General, Restorative, and Neurological Devices

510(k) Number K642295

Page 1 of __

Regulation Number and Section

§ 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.