HBS2 Headless Bone Screw

K171628 · Stuckenbrock Medizintechnik GmbH · HWC · Jan 12, 2018 · Orthopedic

Device Facts

• Record ID: K171628
• Device Name: HBS2 Headless Bone Screw
• Applicant: Stuckenbrock Medizintechnik GmbH
• Product Code: HWC · Orthopedic
• Decision Date: Jan 12, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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: Scaphoid fractures, Scaphoid pseudoarthroses, Proximal pole fractures of the scaphoid, DIP arthrodeses, Metacarpal fractures, Metatarsal fractures, 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, Fractures of the processus styloideus radii

Device Story

HBS2 Headless Bone Screws are cannulated, self-drilling, self-cutting metallic fasteners used in hand, accident, and reconstructive surgery. Designed for internal fixation of small bone fractures and arthrodesis. Operated by surgeons in clinical settings. Screws feature a reversing thread to provide compression across fracture sites or joints. Delivered non-sterile; require reprocessing (cleaning/sterilization) by the facility before use. Output is mechanical stabilization of bone fragments, facilitating healing and joint fusion.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing, including biological safety (cytotoxicity, bioburden, endotoxin, particle testing) and mechanical testing (torsional properties, driving torque, axial pullout strength, and static/dynamic 3-point bending) per ASTM standards.

Technological Characteristics

Material: Ti6Al4V (3.7165). Design: Cannulated, self-drilling, self-cutting headless bone screws with reversing thread. Diameters: 1.7 mm (MINI) and 2.0 mm (MIDI). Mechanical testing per ASTM F543-07, F116-00, F1839-08, F1264-03. Biological safety per EN ISO 10993 series. Delivered non-sterile; requires facility-validated reprocessing.

Indications for Use

Indicated for treatment of intraarticular and extraarticular fractures, pseudoarthroses of small bones/fragments, and arthrodeses of small joints in patients requiring bone fixation.

Regulatory Classification

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

• HBS HEADLESS BONE SCREW, SCHOENING & ASSOC., INC. (K030302)

Reference Devices

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

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

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 ([e-mail]) or phone [phone] 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)

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

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

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: [phone] Internet: www.stuckenbrock.de

Contact Person:

Fabian Stuckenbrock President of Stuckenbrock Medizintechnik GmbH Tel .: [phone] E-Mail: [e-mail]

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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 | Regulation<br>Description | Regulation<br>Medical<br>Specialty | Review<br>Panel | Product<br>Code | Regulation<br>Number | Device<br>Classification |
|--------------------------|----------------------------------------------------------|------------------------------------|-----------------|-----------------|----------------------|--------------------------|
| Screw, fixation,<br>bone | Smooth or threaded<br>metallic bone<br>fixation 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 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.

| Image: Screw with arrows | Ø 3.9 mm<br>Thread pitch 1.0 mm | Image: Screw with arrows |
|--------------------------|----------------------------------|--------------------------|
| | Ø 2.0 mm | |
| Image: Screw with arrows | Ø 3.0 mm<br>Thread pitch 1.25 mm | Image: Screw with arrows |
| | Ø 3.2 mm<br>Thread pitch 0.75 mm | |
| Image: Screw with arrows | Ø 1.7 mm | |
| | Ø 2.5 mm<br>Thread 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 |
|----------------------|--------------------|---------------------------------------------------|
| Biological<br>Safety | EN ISO<br>10993-5 | Cytotoxicity |
| | EN ISO<br>10993-12 | Chemical Analysis |
| | EN ISO<br>10993-18 | Characterization of Organic Extractable |
| | EN ISO<br>11737-1 | Bioburden |
| | USP 85 | LAL Endotoxin |
| | USP 788 | Particle |
| Mechanical<br>Safety | ASTM<br>F543-07 | Torsional properties |
| | ASTM<br>F116-00 | Driving torque |
| | ASTM<br>F1839-08 | Axial pullout strength |
| | ASTM<br>F1264-03 | Static 3-point bending<br>Dynamic 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.