(92 days)
Not Found
No
The summary describes a physical implantable device made of titanium porous metal and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as an implantable titanium porous metal wedge used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot. This directly addresses medical conditions (bone fractures, fusions, osteotomies) to restore or facilitate normal function, which aligns with the definition of a therapeutic device.
No
The device is an implantable wedge used for internal bone fixation and angular correction, not for identifying or diagnosing medical conditions.
No
The device description explicitly states it is a family of "implantable titanium porous metal wedges," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for internal bone fixation during surgical procedures (fractures, fusions, osteotomies). This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description confirms it's an implantable titanium porous metal wedge. This is a physical device used within the body for structural support and correction.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Arthrex BioSync Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies, in the ankle and foot, such as:
Cotton and Evans Wedges:
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Opening wedge of Medial Cuneiform or Cotton osteotomies
- Lateral Column Lengthening (Evans Lengthening Osteotomy of Calcaneal Z Osteotomy)
- Metatarsal/Cuneiform arthrodesis
Midfoot Wedges:
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)
This device is intended for use with ancillary fixation. The Arthrex BioSync Bone Wedge is not intended for use in the spine.
Product codes (comma separated list FDA assigned to the subject device)
PLF, HRS, HWC
Device Description
The Arthrex BioSync Bone Wedge is a family of pre-sized implantable titanium porous metal wedges intended to be used for angular correction of small bones in the ankle and foot. It is offered with varying widths and thicknesses to accommodate a variety of small bone applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle 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 submitted mechanical testing data, inclusive of static compression, dynamic compression and expulsion testing, demonstrates that the wedge is substantially equivalent to that of the predicate devices.
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.
K140531: Wright Medical Technology, Inc. BIOFOAM® Bone Wedge, K141635: Arthrex iBalance® TKA System
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.
Not Found
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2015
Arthrex, Incorporated Ms. Laura Medlin Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K151256 Trade/Device Name: Arthrex BioSync® Bone Wedge Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: PLF, HRS, HWC Dated: May 14, 2015 Received: May 22, 2015
Dear Ms. Medlin:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Ms. Laura Medlin
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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TRADITIONAL 510(K): ARTHREX BIOSYNC BONE WEDGE
2.4 INDICATIONS FOR USE
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| See PRA Statement below. |
Indications for Use
| 510(k) Number ( if known ) | K151256 |
|---|---|
| Device Name | Arthrex BioSync® Bone Wedge |
| Indications for Use ( Describe ) | The Arthrex BioSync Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies, in the ankle and foot, such as: |
Cotton and Evans Wedges:
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Opening wedge of Medial Cuneiform or Cotton osteotomies
- Lateral Column Lengthening (Evans Lengthening Osteotomy of Calcaneal Z Osteotomy)
- Metatarsal/Cuneifrom arthrodesis
Midfoot Wedges:
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)
This device is intended for use with ancillary fixation. The Arthrex BioSync Bone Wedge is not intended for use in the
spine.
| 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) |
|---|---|
| ---------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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"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."
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2.5 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared | August 5, 2015 |
|---|---|
| Manufacturer/ | |
| Distributor/ | |
| Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Laura Medlin |
| Regulatory Affairs | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 72005 | |
| Fax: 239/598.5508 | |
| Email: Laura.Medlin@Arthrex.com | |
| Trade Name | Arthrex BioSync Bone Wedge |
| Common Name | Plate, fixation, bone |
| Screw, fixation, bone | |
| Product Code, | |
| Classification Name | PLF – Bone Wedge |
| HRS - Plate, Fixation, Bone | |
| HWC - Screw, Fixation, Bone | |
| CFR | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances |
| and accessories | |
| 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | |
| Predicate Device | K140531: Wright Medical Technology, Inc. BIOFOAM® Bone Wedge |
| K141635: Arthrex iBalance® TKA System | |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex BioSync Bone Wedge. | |
| Device Description | The Arthrex BioSync Bone Wedge is a family of pre-sized implantable titanium |
| porous metal wedges intended to be used for angular correction of small bones in | |
| the ankle and foot. It is offered with varying widths and thicknesses to | |
| accommodate a variety of small bone applications. | |
| Intended Use | The Arthrex BioSync Bone Wedge is intended to be used for internal bone fixation |
| for bone fractures, fusions, or osteotomies in the ankle and foot, such as: |
Cotton and Evans Wedges:
Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux ValgusOpening wedge of Medial Cuneiform or Cotton osteotomiesLateral Column Lengthening (Evans Lengthening Osteotomy of Calcaneal Z Osteotomy)Metatarsal/Cuneiform arthrodesis
Midfoot Wedges:
Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux ValgusNonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)
This device is intended for use with ancillary fixation. The Arthrex BioSync Bone
Wedge is not intended for use in the spine. |
| Substantial
Equivalence Summary | The Arthrex BioSync Bone Wedge is substantially equivalent to the predicate
devices, in which the basic design features and intended uses are the same. Any
differences between the Arthrex BioSync Bone Wedge and the predicates are
considered minor and do not raise questions concerning safety and effectiveness.
The submitted mechanical testing data, inclusive of static compression, dynamic
compression and expulsion testing, demonstrates that the wedge is substantially |
| | equivalent to that of the predicate devices. Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex, Inc. has determined that the Arthrex BioSync Bone Wedge is substantially equivalent to currently marketed predicate devices. |
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