(260 days)
Not Found
No
The summary describes a mechanical implant for bone fixation and fusion. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies focus on mechanical properties and insertion/distraction resistance, not algorithmic performance.
Yes.
Explanation: The device is indicated for medical purposes such as the "reduction and fixation of fractures," "boney fusion," "non-unions," and "reconstructive procedures." These are all therapeutic actions aimed at treating a medical condition.
No
Explanation: This device is described as an intra-osseous fusion system for fracture reduction, fixation, and reconstructive procedures. Its function is to provide structural support and aid in bone fusion, not to diagnose medical conditions or diseases.
No
The device description explicitly states it consists of titanium alloy rods and beams intended for surgical implantation, which are hardware components.
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 for the internal fixation of fractures, boney fusion, and non-unions and reconstructive procedures within the foot and ankle. This involves surgical implantation to provide structural support and promote healing of bone.
- Device Description: The device is described as titanium alloy triangular-shaped rods and "barbell" shaped beams intended for surgical implantation within the bone. This is a description of a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (like blood, urine, tissue, etc.) from the human body to provide information about a person's health status, diagnose a condition, or monitor treatment.
IVD devices are used in vitro (outside the body) to examine specimens. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The ENDO-FUSE® Intra-Osseous Fusion System Rods are generally indicated for the reduction and fixation of fractures appropriate for the size of the devices. They are indicated for use in the internal fixation of fractures, boney fusion, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies.)
The ENDO-FUSE® Intra-Osseous Fusion System Beams are indicated for lateral column lengthening and for fusions of any joint in the foot/ankle appropriate for the size of the device, including tarso-metatarsal, metatarsalcuneiform, calcaneal-cuboid, talo-navicular, LisFranc, Four-Corner, subtalar, and ankle joint.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The ENDO-FUSE® Intra-Osseous Fusion System consists of titanium alloy triangular-shaped rods and "barbell" shaped beams intended for surgical implantation within the bone to create fixation. The rods are available in various lengths and diameters and the beams in various widths and lengths. Both rods and beams are roughened with a coating of CP titanium plasma spray which is important for achieving fixation via an interference fit inside the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot/ankle, bone
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)
- Mechanical Property Testing of Plasma Spray Coating . Static shear strength testing per ASTM F1044, shear fatigue strength testing per ASTM F1160, and static tensile testing per ASTM F1147 were performed on worst-case coated test coupons. All test specimens passed, per the pre-defined acceptance criteria.
- Fatigue Testing .
Four-point bending fatigue testing was conducted on worst-case subject devices and compared to FDA-cleared devices. Results indicated that the subject devices were able to withstand higher cyclic loads than the predicate, and the acceptance criterion was met. - Cadaveric Rod Insertion Testing .
Rod insertion testing was performed to investigate whether or not any clinically relevant distraction of the distal bone/fracture fragment occurs during rod insertion. The implantation results after insertion were deemed acceptable per the pre-defined acceptance criteria.
Cadaveric and Mechanical Beam Distraction Resistance Testing . Beam distraction resistance testing was performed on subject and predicate devices to show that the subject device could effectively prevent distraction of opposing bones after implantation. The subject device experienced greater distraction resistance than the predicate, and the acceptance criterion was met.
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
§ 888.3040 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
L-102324
MAY - 4 2011
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the ENDO-FUSE® Intra-Osseous Fusion Systems
Submitted By:
Wright Medical Technology, Inc. 5677 Airline Rd. Arlington, TN 38002
Date:
Contact Person:
Proprietary Name:
Common Name:
Classification Name and Reference:
Device Product Code and Panel Code:
Predicate Device
Sarah Holtgrewe Manager, Regulatory Affairs (901) 867-4476
March 30, 2011
ENDO-FUSE® Intra-Osseous Eusion System Fusion Rod and Fusion Beam
21 CFR 888.3040 -Screw, Fixation, Bone --Class II
Orthopedics/87/ HWC
ROI Fusion Rods and Plates (K051309)
DEVICE INFORMATION
A. DEVICE DESCRIPTION
The ENDO-FUSE® Intra-Osseous Fusion System consists of titanium alloy triangular-shaped rods and "barbell" shaped beams intended for surgical implantation within the bone to create fixation. The rods are available in various lengths and diameters and the beams in various widths and lengths. Both rods and beams are roughened with a coating of CP titanium plasma spray which is important for achieving fixation via an interference fit inside the bone.
p. 1 of 3
echnology, Inc. 5677 Airline Road Arlington, TN 38002
1
102324
B. INTENDED USE
The ENDO-FUSE® Intra-Osseous Fusion System Rods are generally indicated for the reduction and fixation of fractures appropriate for the size of the devices. They are indicated for use in the internal fixation of fractures, boney fusion, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies.)
The ENDO-FUSE® Intra-Osseous Fusion System Beams are indicated for lateral column lengthening and for fusions of any joint in the foot/ankle appropriate for the size of the device, including tarso-metatarsal-cuneiform; calcaneal-cuboid, talo-navicular, LisFranc, Four-Corner, subtalar, and ankle joint.
C. PERFORMANCE DATA
The following performance data was used to support the safety and efficacy of the ENDO-FUSE® Intra-Osseous Fusion System:
- Mechanical Property Testing of Plasma Spray Coating . Static shear strength testing per ASTM F1044, shear fatigue strength testing per ASTM F1160, and static tensile testing per ASTM F1147 were performed on worst-case coated test coupons. All test specimens passed, per the pre-defined acceptance criteria.
- Fatigue Testing .
Four-point bending fatigue testing was conducted on worst-case subject devices and compared to FDA-cleared devices. Results indicated that the subject devices were able to withstand higher cyclic loads than the predicate, and the acceptance criterion was met.
- Cadaveric Rod Insertion Testing .
Rod insertion testing was performed to investigate whether or not any clinically relevant distraction of the distal bone/fracture fragment occurs during rod insertion. The implantation results after insertion were deemed acceptable per the pre-defined acceptance criteria.
Cadaveric and Mechanical Beam Distraction Resistance Testing . Beam distraction resistance testing was performed on subject and predicate devices to show that the subject device could effectively prevent distraction of opposing bones after implantation. The subject device experienced greater distraction resistance than the predicate, and the acceptance criterion was met.
D. SUBSTANTIAL EQUIVALENCE INFORMATION
The safety and efficacy of the ENDO-FUSE® Intra-Osseous Fusion System is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this 510(k), including the following: a device description and surgical technique comparison to the predicate, physical and mechanical property analysis of the plasma spray coating, FIEA and mechanical
2
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fatigue testing comparison to predicate, rod insertion testing, an appositional bone analysis compared to predicate, and cadaveric beam distraction resistance testing.
p. 3 of 3
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wings and tail. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. % Ms. Sarah Holtgrewe Manager, Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002
MAY - 4 2011
Re: K102324
Trade Name: Endofuse™ Inta-Osseos Fusion System Regulation Number: 21 CFR 888.3030 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: April 25, 2011 Received: April 26, 2011
Dear Ms. Holtgrewe:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2- Ms. Sarah Holtgrewe
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Alaj B. Pula
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: ENDOFUSE™ Intra-Osseous Fusion System
Indications For Use:
The ENDO-FUSE® Intra-Osseous Fusion System Rods are generally indicated for the reduction and fixation of fractures appropriate for the size of the devices. They are indicated for use in the internal fixation of fractures, boney fusion, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies.)
The ENDO-FUSE® Intra-Osseous Fusion System Beams are indicated for lateral column lengthening and for fusions of any joint in the foot/ankle appropriate for the size of the device, including tarso-metatarsal, metatarsalcuneiform, calcaneal-cuboid, talo-navicular, LisFranc, Four-Corner, subtalar, and ankle joint.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 of 1
for M. Melkerson
(Division Sinn-Off) (Division Sign-Sical, Orthopedic, Division of Sweet and Restorative Devices
510(k) Number K102324