(241 days)
No
The summary describes a mechanical implant system made of Nitinol and titanium alloy, with no mention of software, algorithms, or any technology related to AI or ML.
Yes.
The device is an implantable system designed to fix fractures, fusions, or osteotomies, which is a therapeutic purpose.
No
The device is a nitinol implant intended for fixation of fractures, fusions, or osteotomies, not for diagnosis.
No
The device description explicitly states it is a nitinol implant and includes details about materials, configurations, and bone screw options, indicating it is a physical hardware device.
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 device is for "fixation of fractures, fusions, or osteotomies of the hand and foot." This describes a surgical implant used in vivo (within the body) to provide structural support and stability to bone.
- Device Description: The description details a "nitinol implant" and "bone screw assembly" which are components of a surgical device, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the NeoSpan® Compression Implant System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NeoSpan® Compression Implant System is a nitinol implant intended to provide fixation of fractures, fusions, or osteotomies of the hand and foot.
Product codes (comma separated list FDA assigned to the subject device)
HRS, JDR, HWC
Device Description
In2Bones NeoSpan® Compression Implant System (CIS) is a product expansion of the existing NeoSpan Compression Staple Implant w/ Instruments (K161426). The NeoSpan® Compression Implant System consists of implants offered in various configurations from 2 and 3 legs with no hole or 1-to-3 holes intended for bone screw assembly for additional fixation. The fixed-leg implants are comprised of Nitinol per ASTM F2063. The devices are sterile implants intended to provide fixation of fractures, fusions, or osteotomies of the hand and foot.
Bone screw options for the NeoSpan® Compression Implant System are previously cleared 3.0mm and 3.5mm locking and non-locking screws in lengths 10-30mm made from titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand and foot
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)
The NeoSpan® Compression Implant System was evaluated against the predicates per ASTM F564 (Static Bending, Fatigue Bending, Pull-Out) and was shown to be substantially equivalent to the predicate implants. Corrosion testing per ASTM F2129 & ASTM F3044 was conducted for the subject device. The NeoSpan® Compression Implant System was validated per ISO 10993-1 for biocompatibility, ISO 11137-2 for gamma sterilization and ISO 11607-1 for packaging. Endotoxin testing was completed per ANSI/AAMI ST72.
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.
K161426, K160300, K222645, K112837
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
May 24, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
In2Bones USA, LLC Christine Scifert VP, Quality and Regulatory 6000 Poplar Ave, Suite 115 Memphis, Tennessee 38002
Re: K233089
Trade/Device Name: NeoSpan® Compression Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC, JDR Dated: April 25, 2024 Received: April 25, 2024
Dear Christine Scifert:
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/cdrh/cfdocs/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.
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).
1
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 -S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K233089
Device Name NeoSpan® Compression Implant System
Indications for Use (Describe)
The NeoSpan® Compression Implant System is a nitinol implant intended to provide fixation of fractures, fusions, or osteotomies of the hand and foot.
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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3
K233089
510(k) Summary
NeoSpan® Compression Implant System May 24, 2024
| Company: | In2Bones USA, LLC
6000 Poplar Ave, Suite 115
Memphis, TN 38119
901-260-7931 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert |
| Trade Name: | NeoSpan® Compression Implant System |
| Common Name: | Plate, Fixation, Bone; Staple, Fixation, Bone; Screw, Fixation, Bone |
| Classification: | II |
| Regulation Number: | 888.3030 - Single/multiple component metallic bone fixation appliances
and accessories (primary)
888.3040 - Smooth or threaded metallic bone fixation fastener |
| Panel: | 87-Orthopedic |
| Product Code(s): | HRS (primary), JDR
HWC |
Device Description: In2Bones NeoSpan® Compression Implant System (CIS) is a product expansion of the existing NeoSpan Compression Staple Implant w/ Instruments (K161426). The NeoSpan® Compression Implant System consists of implants offered in various configurations from 2 and 3 legs with no hole or 1-to-3 holes intended for bone screw assembly for additional fixation. The fixed-leg implants are comprised of Nitinol per ASTM F2063. The devices are sterile implants intended to provide fixation of fractures, fusions, or osteotomies of the hand and foot.
Bone screw options for the NeoSpan® Compression Implant System are previously cleared 3.0mm and 3.5mm locking and non-locking screws in lengths 10-30mm made from titanium alloy.
Indications for Use: The NeoSpan® Compression Implant System is a nitinol implant intended to provide fixation of fractures, fusions, or osteotomies of the hand and foot.
4
K233089
Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:
Primary Predicate
-
. K161426 -NeoSpan Compression Staple Implant w/ Instruments
Additional Predicate -
. K160300 - CrossRoads Extremity Systems MotoBAND Implant System
-
K222645 Treace Medical Compression Implant System .
-
. K112837 - Vilex eZ-Staple Superelastic Bone Fixation Staple
Reference Device
The subject NeoSpan® Compression Implant System is similar geometry to the previously cleared CrossRoads Extremity Systems MotoBAND Implant System and Treace Medical Compression Implant System. The NeoSpan® Compression Implant System has been demonstrated to be substantially equivalent to the previously cleared devices identified above as the products are similar in indications, materials and geometry.
Performance Testing: The NeoSpan® Compression Implant System was evaluated against the predicates per ASTM F564 (Static Bending, Fatigue Bending, Pull-Out) and was shown to be substantially equivalent to the predicate implants. Corrosion testing per ASTM F2129 & ASTM F3044 was conducted for the subject device. The NeoSpan® Compression Implant System was validated per ISO 10993-1 for biocompatibility, ISO 11137-2 for gamma sterilization and ISO 11607-1 for packaging. Endotoxin testing was completed per ANSI/AAMI ST72.
Conclusion
Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.