(257 days)
No
The device description and performance studies focus on the mechanical properties and sterilization of bone screws and K-wires, with no mention of AI or ML.
Yes
Both the Cannulated Headless Bone Screws and K-Wires are indicated for use in fixation, osteotomy, and arthrodesis of human bones, which are therapeutic interventions.
No
Explanation: The device, consisting of Cannulated Headless Bone Screws and K-Wires, is indicated for non-spinal fragment fixation, osteotomy, and arthrodesis, which are surgical procedures for treating bone conditions. Its function is to fix bone fragments or guide osteosynthesis implants, not to diagnose medical conditions or provide information for diagnosis.
No
The device description clearly states that the device is a physical bone screw and K-wire, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for "non-spinal fragment fixation, osteotomy and arthrodesis of human bones." This describes a surgical procedure performed directly on the body, not a test performed on a sample taken from the body.
- Device Description: The description details bone screws and K-wires, which are implants used in orthopedic surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The devices described here are surgical implants.
N/A
Intended Use / Indications for Use
Cannulated Headless Bone Screws
The aap Cannulated Headless Bone Screws are indicated for use in non-spinal fragment fixation, osteotomy and arthrodesis of human bones appropriate for the size of the screw. The devices are intended for single use only.
K-Wire
K-Wires are indicated for use as guide wire for osteosynthesis implants and for application as implant according to the AO/ASIF principles of fracture management.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTY
Device Description
The subject device Cannulated Headless Bone Screws are cannulated at both the leading end (tip) and at the trailing end. The leading/trailing diameters are: 2.5/3.4 mm. 3.5/4.5 mm. 4.0/4.8 mm. 4.5/5.3 mm, 5.5/6.2 mm, 6.5/7.2 mm, and 7.5/7.9 mm., The leading thread have different pitches which facilitates closure of any fracture gap and generates compression across the bone fragments. The subject screws are provided in overall lengths ranging from 12 mm, and with threaded lengths (at the leading end or tip) ranging from 4 mm to 40 mm. The subject screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and ISO 5832-3.
The subject K-Wire is provided in one size with a diameter of 2.4 mm and a length of 250 mm. The subject K-Wire has a trocar point, is threaded, and is manufactured from stainless steel conforming to ASTM F138 and ISO 5832-1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human bones (non-spinal)
Indicated Patient Age Range
The aap Cannulated Headless Bone Screws are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.
The K-Wires are indicated for adults, and children (2 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.
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)
Non-clinical data submitted or referenced to demonstrate substantial equivalence included:
- referenced from for the primary predicate K111316 and the reference devices K130590 and K131459 . was moist heat sterilization validation to a sterility assurance level of 10° by the overkill method according to ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO TIR 17665-2, and ANSI/AAMI/ISO 14937; analysis showed that the subject devices do not create a new worst case for moist heat sterilization;
- referenced from K111316, K130590, and K131459 was packaging and shelf life information for the subject . devices:
- referenced from K111316, K130590, K131459 was biocompatibility for the subject device materials; ●
- provided in this submission was mechanical testing of the subject device screws according to ASTM F543. ●
No clinical data were included in this submission.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 5, 2024
aap Implantate AG % Kevin Thomas Vice President & Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K233008
Trade/Device Name: Cannulated Headless Bone Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: May 14, 2024 Received: May 14, 2024
Dear Kevin Thomas:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices
2
OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233008
Device Name
Cannulated Headless Bone Screws
Indications for Use (Describe)
Cannulated Headless Bone Screws
The aap Cannulated Headless Bone Screws are indicated for use in non-spinal fragment fixation, osteotomy and arthrodesis of human bones appropriate for the size of the screw. The devices are intended for single use only. The aap Cannulated Headless Bone Screws are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.
K-Wire
K-Wires are indicated for use as guide wire for osteosynthesis implants and for application as implant according to the AO/ASIF principles of fracture management.
The K-Wires are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) Summary K233008 Cannulated Headless Bone Screws aap Implantate AG
May 30, 2024
ADMINISTRATIVE INFORMATION
| Manufacturer Name | aap Implantate AG |
|---|---|
| Lorenzweg 5 | |
| 12099 Berlin Germany | |
| Telephone +49 30 750 19 129 | |
| Fax +49 30 750 19 111 | |
| Official Contact | Agnieszka Mierzejewska, Chief Operating Officer |
| Representative/Consultant | Kevin A. Thomas, PhD |
| Floyd G. Larson, MS, MBA | |
| PaxMed International, LLC | |
| 12264 El Camino Real, Suite 400 | |
| San Diego, CA 92130 | |
| Telephone +1 858-792-1235 | |
| Fax +1 858-792-1236 | |
| Email kthomas@paxmed.com | |
| flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Device Name
Common Name | Cannulated Headless Bone Screws
Screw, fixation, bone |
|----------------------------------|----------------------------------------------------------------------------|
| Regulation Number | 21 CFR 888.3040 |
| Regulation Name | Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | Class II |
| Primary Product Code | HWC |
| Additional Product Codes | HTY |
| Classification Panel | Orthopedic |
| Reviewing Office | Office of Health Technology 6 (OHT 6: Orthopedic Devices) |
| Reviewing Division | Division of Health Technology 6 C (Restorative, Repair and Trauma Devices) |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K111316, aap Cannulated Screws, aap Implantate AG
Reference Devices K130590, aap Cannulated Screw 2.0, aap Implantate AG K131459, aap Wire Bone, aap Implantate AG K 161616, DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless, Synthes USA Products, LLC
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INDICATIONS FOR USE STATEMENT
Cannulated Headless Bone Screws
The aap cannulated headless bone screws are indicated for use in non-spinal fracture and fragment fixation, osteotomy and arthrodesis of human bones appropriate for the screw. The devices are intended for single use only. The aap Cannulated Headless Bone Screws are indicated for adults, and children (2 years to less than 12 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.
K-Wire
K-Wires are indicated for use as guide wire for osteosynthesis implants and for application as implant according to the AO/ASIF principles of fracture management.
The K-Wires are indicated for adults, and children (2 years) and adolescents (aged 12 through 21, up to but not including the 22nd birthday) in which growth plates have fused or in which growth plates will not be crossed by fixation.
SUBJECT DEVICE DESCRIPTION
The subject device Cannulated Headless Bone Screws are cannulated at both the leading end (tip) and at the trailing end. The leading/trailing diameters are: 2.5/3.4 mm. 3.5/4.5 mm. 4.0/4.8 mm. 4.5/5.3 mm, 5.5/6.2 mm, 6.5/7.2 mm, and 7.5/7.9 mm., The leading thread have different pitches which facilitates closure of any fracture gap and generates compression across the bone fragments. The subject screws are provided in overall lengths ranging from 12 mm, and with threaded lengths (at the leading end or tip) ranging from 4 mm to 40 mm. The subject screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and ISO 5832-3.
The subject K-Wire is provided in one size with a diameter of 2.4 mm and a length of 250 mm. The subject K-Wire has a trocar point, is threaded, and is manufactured from stainless steel conforming to ASTM F138 and ISO 5832-1.
PERFORMANCE DATA
Recognized standards used in the non-clinical performance testing included:
ASTM F136 (2013) Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401);
ISO 5832-3 (2021) Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4vanadium alloy;
ASTM F138 (2019) Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673);
ISO 5832-1 (2016) Implants for surgery - Metallic materials - Part 1: Wrought stainless steel;
ISO 17665-1 (2006) Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices:
ISO 17665-2 (2009) Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1;
ISO 10993-1 (2018) Biological evaluation of medical devices – Part I : Evaluation and testing within a risk management process; and
ASTM F543 (2017) Standard Specification and Test Methods for Metallic Medical Bone Screws.
Non-clinical data submitted or referenced to demonstrate substantial equivalence included:
- referenced from for the primary predicate K111316 and the reference devices K130590 and K131459 . was moist heat sterilization validation to a sterility assurance level of 10° by the overkill method according to
6
ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO TIR 17665-2, and ANSI/AAMI/ISO 14937; analysis showed that the subject devices do not create a new worst case for moist heat sterilization;
- referenced from K111316, K130590, and K131459 was packaging and shelf life information for the subject . devices:
- referenced from K111316, K130590, K131459 was biocompatibility for the subject device materials; ●
- provided in this submission was mechanical testing of the subject device screws according to ASTM F543. ●
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject device, the primary predicate device K111316, and the reference devices K130590 and K131459 have the same technological characteristics and use the same operating principles for bone fracture fixation (bone screws and K-Wire) or for use as an instrument (K-Wire to facilitate placement of cannulated screws). The reference device K161616 is to support the use of the subject screws in the pediatric population.
The subject device bone screws are provided in ranges of thread diameters, threaded lengths that are similar to the primary predicate K111316 and the reference device K130590. The subject screw designs also are similar to the designs of screws cleared in K111316 and K130590.
The subject device K-Wire has a diameter of 2.4 mm, an overall length of 250 mm, and a trocar point. These dimensions are within the range of K-Wires (with trocar point) cleared in K131459.
The subject device screws are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3 using materials and processes identical to that used for screws cleared in the primary predicate device K111316 and the reference device K130590.
The subject device K-Wire is manufactured from stainless steel confirming to ASTM F138 or ISO 5832-1 using processes identical to that used for K-Wires cleared in the reference device submission K131459.
All subject device final finished components are manufactured in the same facilities using identical and identical manufacturing processes as used for the previously cleared aap device components. Therefore, the subject devices are substantially equivalent to predicate devices regarding biocompatibility.
The subject device components are provided non-sterile in the same packaging as in the primary predicate K111316 and the reference devices K130590 and K131459, and are to be sterilized to a sterility assurance level (SAL) of 10 the end user using the same sterilization method (moist heat) and parameters as the previously cleared devices. The subject devices do not represent a new worst-case for the sterilization.
In support of substantial equivalence of the subject device screws mechanical testing was performed according to ASTM F543.
CONCLUSION
The subject devices, the primary predicate device, and the reference devices have the same intended use and similar technological characteristics. They encompass a similar range of physical dimensions, are manufactured from the same materials, and are to be sterilized using identical methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.