HBS2 Headless Bone Screw is used for the treatment of intraarticular fractures and pseudoarthroses of smaller bones and bone fragments as well as for arthrodeses on small joints, especially in the scope of:

HBS2 MIDI: Scaphoid fractures, Scaphoid pseudoarthroses, Proximal pole fractures of the scaphoid, DIP arthrodeses, Metacarpal fractures, Metatarsal fractures of the processus styloideus ulnae, Proximal radial head fractures

HBS2 MINI: Scaphoid fractures, Scaphoid pseudoarthroses, Proximal pole fractures of the scaphoid, DIP arthrodeses, Metacarpal fractures, Fractures of the processus styloideus ulnae, Proximal radial head fractures of the processus styloideus radii

Device Description

The HBS2 Headless Bone Screws are used in the field of hand surgery, accident surgery and reconstructive surgery, and in orthopedics for the treatment of intraarticular and extra articular fractures and pseudo arthroses of small bone fragments, and for arthrodesis on small joints.

The system consists of various screws and instruments for different treatment options.

HBS2 screws are cannulated, self-drilling, self-cutting, have a reversing thread and are available in two diameters with different thread lengths.

HBS2 MIDI screws (magenta) are available with a diameter of 2.0 mm (shaft) and in different lengths. HBS2 MINI screws (green) are available with a diameter of 1.7 mm (shaft) and in different lengths too.

These devices are delivered in non-sterile condition and must be reprocessed before use. All implants are made out of Ti6Al4V 3.7165.

AI/ML Overview

The provided text is a 510(k) summary for the HBS2 Headless Bone Screw. It details the device's indications for use, description, classification, and comparison to predicate devices. It explicitly states that no clinical studies were performed for this device, and therefore, an AI/ML-based study with acceptance criteria, ground truth, and expert evaluation as described in the prompt is not applicable to this document.

The document primarily focuses on non-clinical tests to demonstrate substantial equivalence to legally marketed predicate devices. The non-clinical tests are summarized in a table, which includes standards for biological safety (cytotoxicity, chemical analysis, characterization of organic extractable, bioburden, LAL endotoxin, particle) and mechanical safety (torsional properties, driving torque, axial pullout strength, static and dynamic 3-point bending).

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML-based device and its study, as this document pertains to a medical device that was evaluated through non-clinical testing and substantial equivalence, not through AI/ML performance studies.

Summary

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January 12, 2018

Stuckenbrock Medizintechnik GmbH Fabian Stuckenbrock President Lessingstrasse 50 78532 Tuttlingen Germany

Re: K171628

Trade/Device Name: HBS2 Headless Bone Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: December 26, 2017 Received: December 18, 2017

Dear Fabian Stuckenbrock:

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171628

Device Name HBS2 Headless Bone Screw

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Stuckenbrock Medizintechnik ein Unternehmen der KLS MOITEIN Group

K171628

510(k) Summary

Issue Date:

18-12-2017

510(k) Owner´s Name: Stuckenbrock Medizintechnik GmbH Lessingstrasse 50 78532 Tuttlingen Germany Tel: + 49 (0)7461/165880 Fax: +49 (0)7461/4194 Internet: www.stuckenbrock.de

Contact Person:

Fabian Stuckenbrock President of Stuckenbrock Medizintechnik GmbH Tel .: +49 7461 165880 E-Mail: f.Stuckenbrock@stuckenbrock.de

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1. General Info

1.1. Device Name

Trade Name: HBS2 Headless Bone Screw

Common Name: Bone fixation screw

Classification Name: Screw, fixation, bone

1.2. Classification Product Code

Stuckenbrock HBS2 Headless Bone Screw can be classified according to following device name and product code:

Device	RegulationDescription	RegulationMedicalSpecialty	ReviewPanel	ProductCode	RegulationNumber	DeviceClassification
Screw, fixation,bone	Smooth or threadedmetallic bonefixation fastener	Orthopedic	Orthopedic	HWC	888.3040	2

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2. Indication for Use

HBS2 Headless Bone Screw is used for the treatment of intraarticular and extraarticular fractures and pseudoarthroses of smaller bones and bone fragments as well as for arthrodeses on small joints, especially in the scope of:

□ HBS2 MIDI:

י Scaphoid fractures
Scaphoid pseudoarthroses .
I Proximal pole fractures of the scaphoid
DIP arthrodeses I
. Metacarpal fractures
I Metatarsal fractures
Fractures of the processus styloideus ulnae .
I Proximal radial head fractures

0 HBS2 MINI:

Scaphoid fractures ■
Scaphoid pseudoarthroses .
I Proximal pole fractures of the scaphoid
DIP arthrodeses '
. Metacarpal fractures
Fractures of the processus styloideus ulnae .
Proximal radial head fractures
Fractures of the processus styloideus radii ■

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3. Device Description

The system consists of various screws and instruments for different treatment options.

HBS2 screws are cannulated, self-drilling, self-cutting, have a reversing thread and are available in two diameters with different thread lengths.

Image: Screw with arrows	Ø 3.9 mmThread pitch 1.0 mm	Image: Screw with arrows
	Ø 2.0 mm
Image: Screw with arrows	Ø 3.0 mmThread pitch 1.25 mm	Image: Screw with arrows
	Ø 3.2 mmThread pitch 0.75 mm
Image: Screw with arrows	Ø 1.7 mm
	Ø 2.5 mmThread pitch 1.0 mm

These devices are delivered in non-sterile condition and must be reprocessed before use. All implants are made out of Ti6Al4V 3.7165.

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4. Predicate Devices

4.1. Primary Predicate Device

□ HBS HEADLESS BONE SCREW, SCHOENING & ASSOC., INC., K030302

4.2. Secondary Predicate or Reference Devices

□ SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW, SYNTHES (USA), K021556
SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS, SYNTHES (USA), K050636

4.2.1. Substantial Equivalence Claimed to predicate Devices

The Stuckenbrock HBS2 headless bone screws are substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance.

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5. Clinical and Non-Clinical Test Summary

5.1. Clinical Tests

No clinical studies were performed.

Non-Clinical Test Summary 5.2.

The follow tests have been conducted:

Topic	Standard	Test
BiologicalSafety	EN ISO10993-5	Cytotoxicity
	EN ISO10993-12	Chemical Analysis
	EN ISO10993-18	Characterization of Organic Extractable
	EN ISO11737-1	Bioburden
	USP 85	LAL Endotoxin
	USP 788	Particle
MechanicalSafety	ASTMF543-07	Torsional properties
	ASTMF116-00	Driving torque
	ASTMF1839-08	Axial pullout strength
	ASTMF1264-03	Static 3-point bendingDynamic 3-point bending

Sensible manufacturing processes have been validated (e.g. Final Cleaning). Furthermore, reprocessing process has been validated in terms of:

0 Pre-Treatment
O Manual Cleaning
□ Automated Cleaning/Disinfection (thermal disinfection)
□ Drying
□ Sterilization

5.2.1. Conclusions Non-Clinical Tests

Stuckenbrock considers the HBS2 headless bone screws to be equivalent to the predicate devices listed above. This conclusion is based upon the device's similarities in principles of operation, technology, materials, and indications for use.

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.