(260 days)
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, metatarsal-cuneiform, calcaneal-cuboid, talo-navicular, LisFranc, Four-Corner, subtalar, and ankle joint.
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.
The ENDO-FUSE® Intra-Osseous Fusion System is supported by several performance tests demonstrating its safety and efficacy.
1. Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Property Testing of Plasma Spray Coating (ASTM F1044, ASTM F1160, ASTM F1147) | "Pre-defined acceptance criteria" (specific numerical values not provided, but generally related to minimum shear and tensile strengths) | All test specimens passed, meeting the pre-defined acceptance criteria for static shear strength, shear fatigue strength, and static tensile strength. |
| Fatigue Testing (Four-point bending) | Ability to withstand cyclic loads at least equivalent to the predicate device. | Subject devices were able to withstand higher cyclic loads than the predicate device, meeting the acceptance criterion. |
| Cadaveric Rod Insertion Testing | "Clinically relevant distraction of the distal bone/fracture fragment" does not occur during rod insertion. | Implantation results after insertion were deemed acceptable per the pre-defined acceptance criteria, indicating no clinically relevant distraction. |
| Cadaveric and Mechanical Beam Distraction Resistance Testing | Effective prevention of distraction of opposing bones after implantation, at least equivalent to the predicate device. | The subject device experienced greater distraction resistance than the predicate, meeting the acceptance criterion. |
2. Sample Size and Data Provenance
- Plasma Spray Coating Tests: Performed on "worst-case coated test coupons." The exact number of coupons or samples is not specified.
- Fatigue Testing: Conducted on "worst-case subject devices." The exact number of devices tested is not specified.
- Cadaveric Rod Insertion Testing: Performed using cadaveric models. The number of cadavers or limbs used is not specified.
- Cadaveric and Mechanical Beam Distraction Resistance Testing: Performed using cadaveric models and mechanical testing. The number of cadavers/limbs and mechanical test samples is not specified.
The provenance of the data (country of origin, retrospective or prospective) is not explicitly stated, but the testing appears to be primarily laboratory-based and cadaveric studies conducted by the manufacturer, Wright Medical Technology, Inc., located in Arlington, TN, USA.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for the performance tests. The tests are primarily mechanical and cadaveric studies and rely on objective measurements and predefined engineering criteria rather than expert clinical assessment of outcomes.
4. Adjudication Method
No adjudication method is mentioned, as the studies are mechanical and cadaveric engineering tests, not clinical trials requiring expert adjudication of patient outcomes or image interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study involves human readers interpreting cases with and without AI assistance and is irrelevant for a bone fixation system.
6. Standalone Performance (Algorithm Only)
Not applicable. The ENDO-FUSE® Intra-Osseous Fusion System is a physical medical device, not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth for the performance tests is based on:
- Established engineering standards: ASTM F1044, ASTM F1160, and ASTM F1147 for material properties.
- Comparative mechanical performance: Against an FDA-cleared predicate device.
- Physical observation and measurement: In cadaveric models for rod insertion and distraction resistance.
8. Sample Size for Training Set
Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.
9. How Ground Truth for Training Set was Established
Not applicable. As there is no training set for a physical device, no ground truth was established for it.
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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.
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echnology, Inc. 5677 Airline Road Arlington, TN 38002
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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
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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.
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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
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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
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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)
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for M. Melkerson
(Division Sinn-Off) (Division Sign-Sical, Orthopedic, Division of Sweet and Restorative Devices
510(k) Number K102324
§ 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.