(307 days)
Not Found
No
The summary describes a passive, additively manufactured bone wedge for fixation, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No
The device is described as a "Bone Wedge System" used for internal bone fixation for fractures or osteotomies, and it is made of titanium alloy. It is an implantable device used to stabilize bone, not to treat a disease or condition in a therapeutic sense, but rather to aid in surgical repair.
No
The device is described as "wedge-shaped devices intended to be used for internal bone fixation for bone fractures or osteotomies." It does not mention any function related to diagnosing or identifying medical conditions.
No
The device description explicitly states the device is a series of wedge-shaped devices additively manufactured from medical grade titanium alloy, indicating it is a physical implant, not software.
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.
- Device Description: The Additive Orthopaedics Bone Wedges are described as "wedge-shaped devices intended to be used for internal bone fixation for bone fractures or osteotomies in the foot and ankle." They are implants made of titanium alloy.
- Intended Use: The intended use is for "internal bone fixation for bone fractures or osteotomies." This is a surgical procedure involving the physical placement of a device within the body to stabilize bone.
The device is a surgical implant used directly within the body for structural support, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Additive Orthopaedics Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
*Cotton (opening wedge) osteotomies of the medial cuneiform
*Evans lengthening osteotomies
The Additive Orthopaedics Bone Wedges are intended for use with ancillary plating fixation.
The Additive Orthopaedics Bone Wedges are not intended for use in the spine.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Additive Orthopaedics Bone Wedge System is a series of wedge-shaped devices intended to be used for internal bone fixation for bone fractures or osteotomies in the foot and ankle. The wedges are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). The implants are provided sterile and intended for single use only. The wedges come in 18 individual sizes and configurations to correct various skeletal deformities in the foot. The Additive Orthopaedics Bone Wedge System is intended to be used with ancillary plating fixation.
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
Prescription Use
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)
Morphological characterization, mechanical testing (including, friction, roughness, durability/abrasion, and compressive fatigue) as well as biocompatibility testing were performed on the proposed device. The results of these verification activities demonstrate that the Additive Orthopaedics Bone Wedges are substantially equivalent to the predicate device identified.
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.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 7, 2016
Additive Orthopaedics, LLC Mr. Gregory Kowalczyk President 83 Amelia Circle Little Silver, New Jersey 07739
Re: K153207
Trade/Device Name: Additive Orthopaedics Bone Wedge 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 Dated: July 29, 2016 Received: August 5, 2016
Dear Mr. Kowalczyk:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) 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/Resourcesfor You/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.
Sincerely,
Mark N. Melkerson -S
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) K153207 (page 1 of 1)
Device Name Additive Orthopaedics Bone Wedge System
Indications for Use (Describe)
The Additive Orthopaedics Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
*Cotton (opening wedge) osteotomies of the medial cuneiform *Evans lengthening osteotomies
The Additive Orthopaedics Bone Wedges are intended for use with ancillary plating fixation.
The Additive Orthopaedics Bone Wedges are not intended for use in the spine.
| 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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510K Summary (Per 21 CFR 807.92)
| General Company Information: | Additive Orthopaedics, LLC.
Gregory Kowalczyk
President
83 Amelia Circle
Little Silver, NJ 07739
Phone: (732) 882-6633
greg@additiveortho.com |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | September 7, 2016 |
General Device Information:
| Proprietary Name: | Additive Orthopaedics Bone Wedge System |
|---|---|
| ------------------- | ----------------------------------------- |
| System Classification: | Common Name: Bone Wedge System
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories;
Product Code: HRS- Class II
Classification Name and Reference: 21 CFR 888.3030 |
| ------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Predicate Devices:
| Company | Product Name | 510K Number |
|---|---|---|
| Primary: Integra, Inc. | ||
| Additional: 4-Web, Inc. | Integra Titanium Bone Wedges | |
| Web Osteotomy Bone Wedge | K131360 | |
| K130185 |
Description
The Additive Orthopaedics Bone Wedge System is a series of wedge-shaped devices intended to be used for internal bone fixation for bone fractures or osteotomies in the foot and ankle. The wedges are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). The implants are provided sterile and intended for single use only. The wedges come in 18 individual sizes and configurations to correct various skeletal deformities in the foot. The Additive Orthopaedics Bone Wedge System is intended to be used with ancillary plating fixation.
4
Intended Use (Indications)
The Additive Orthopaedics Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
*Cotton (opening wedge) osteotomies of the medial cuneiform
*Evans lengthening osteotomies
The Additive Orthopaedics Bone Wedges are intended for use with ancillary plating fixation.
The Additive Orthopaedics Bone Wedges are not intended for use in the spine.
(a) (6) Technological Characteristics Comparison
The Additive Orthopaedics Bone Wedge System and the legally marketed predicated devices have similar indications, dimensions, geometry and materials. The Additive Orthopaedics Bone Wedge System is technologically substantially equivalent to the predicate devices.
(b) (1) Substantial Equivalence- Non-Clinical Evidence
Morphological characterization, mechanical testing (including, friction, roughness, durability/abrasion, and compressive fatigue) as well as biocompatibility testing were performed on the proposed device. The results of these verification activities demonstrate that the Additive Orthopaedics Bone Wedges are substantially equivalent to the predicate device identified.
(b) (3) Substantial Equivalence
The Additive Orthopaedics Bone Wedge System possesses the same technologic characteristics of the predicate devices. These characteristics include the intended use, basic design, material, size and fundamental technology. The design characteristics of the subject system do not raise any new types of questions of safety and effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.