(224 days)
No
The device description and intended use are for a mechanical bone screw system. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are focused on mechanical and biological safety, not algorithmic performance.
Yes
The device, a headless bone screw, is used for the treatment of fractures and pseudoarthroses, which are conditions that require therapeutic intervention.
No
Explanation: The HBS2 Headless Bone Screw is used for the treatment of fractures and pseudoarthroses, and for arthrodeses on small joints. It is an implantable device used for treatment, not for diagnosis.
No
The device description clearly states it consists of "various screws and instruments" and describes the physical characteristics of these implants (cannulated, self-drilling, made of Ti6Al4V). This indicates it is a physical medical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The HBS2 Headless Bone Screw is a surgical implant used to treat fractures and perform arthrodeses within the body. It is a physical device inserted into bone.
- No Mention of Samples or Testing: The description and intended use do not involve analyzing any biological samples or performing any diagnostic tests.
Therefore, based on the provided information, the HBS2 Headless Bone Screw is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
smaller bones and bone fragments, small joints, Scaphoid, DIP, Metacarpal, Metatarsal, processus styloideus ulnae, Proximal radial head, processus styloideus radii
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)
No clinical studies were performed.
Non-Clinical Tests:
Biological Safety:
- Cytotoxicity (EN ISO 10993-5)
- Chemical Analysis (EN ISO 10993-12)
- Characterization of Organic Extractable (EN ISO 10993-18)
- Bioburden (EN ISO 11737-1)
- LAL Endotoxin (USP 85)
- Particle (USP 788)
Mechanical Safety:
- Torsional properties (ASTM F543-07)
- Driving torque (ASTM F116-00)
- Axial pullout strength (ASTM F1839-08)
- Static 3-point bending, Dynamic 3-point bending (ASTM F1264-03)
Manufacturing processes, including Final Cleaning, were validated. Reprocessing processes (Pre-Treatment, Manual Cleaning, Automated Cleaning/Disinfection (thermal disinfection), Drying, Sterilization) were also validated.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Stuckenbrock Medizintechnik ein Unternehmen der KLS MOITEIN Group
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
4
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
Description | Regulation
Medical
Specialty | Review
Panel | Product
Code | Regulation
Number | Device
Classification |
|--------------------------|----------------------------------------------------------|------------------------------------|-----------------|-----------------|----------------------|--------------------------|
| Screw, fixation,
bone | Smooth or threaded
metallic bone
fixation fastener | Orthopedic | Orthopedic | HWC | 888.3040 | 2 |
5
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 ■
6
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
Thread pitch 1.0 mm | Image: Screw with arrows |
|--------------------------|----------------------------------|--------------------------|
| | Ø 2.0 mm | |
| Image: Screw with arrows | Ø 3.0 mm
Thread pitch 1.25 mm | Image: Screw with arrows |
| | Ø 3.2 mm
Thread pitch 0.75 mm | |
| Image: Screw with arrows | Ø 1.7 mm | |
| | Ø 2.5 mm
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.
7
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.
8
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 | ||
| Safety | EN ISO | |
| 10993-5 | Cytotoxicity | |
| EN ISO | ||
| 10993-12 | Chemical Analysis | |
| EN ISO | ||
| 10993-18 | Characterization of Organic Extractable | |
| EN ISO | ||
| 11737-1 | Bioburden | |
| USP 85 | LAL Endotoxin | |
| USP 788 | Particle | |
| Mechanical | ||
| Safety | ASTM | |
| F543-07 | Torsional properties | |
| ASTM | ||
| F116-00 | Driving torque | |
| ASTM | ||
| F1839-08 | Axial pullout strength | |
| ASTM | ||
| F1264-03 | Static 3-point bending | |
| 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.