(89 days)
The intended use of the I.T.S. CONNEXX Locking Tibia Nail is to stabilize fractures of the proximal and distal tibia and the tibial shaft in a pediatric or adult patient. Indications for use include open and closed tibial shaft fractures; certain pre and post-isthmic fractures, tibial malunions and non-unions, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, metaphyseal and epiphyseal fractures, transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, bone support, and fractures with bone loss.
The I.T.S. CONNEXX Locking Tibia Nail is a fracture fixation intramedullary rod with locking/nonlocking cross-screw fixation for repairing long bone tibia fractures of a patient. The I.T.S. CONNEXX Locking Tibia Nail System is composed of a cannulated 9mm and 10mm diameter nail in various lengths (255mm to 420mm in 15mm increments) and two styles of cross-screw attachments, a 4.7mm standard cortical screw as a non-locking feature and a 4.7mm Bolt Double Thread as a non-locking feature (two thread diameters on the screw for thread engagement into the proximal and distal cortex of the tibial shaft when inserted). A cannulated 'locking key sleeve' and 'end cap' combination function to firmly fix the above two cross-screw attachments to the 9mm or 10mm nail for 'locking' the cross-screws to the tibia nail - thus making the entire IM rod/cross-screw assembly 'angle-stable locking'. All tibial rods and cross-screws are composed of high strength 6-4 ELI Titanium Alloy to ASTM F-136. A full compliment of instrumentation is available for use with the system.
The provided text is a 510(k) summary for the I.T.S. CONNEXX Locking Tibia Nail. It outlines the device's description, intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
Instead of performance criteria and a study to prove it, the document focuses on demonstrating substantial equivalence to existing legally marketed devices. This is a common pathway for medical device approval in the United States, where a new device is shown to be as safe and effective as a predicate device already on the market, rather than necessarily performing a specific quantitative benchmark study.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the document.
- Sample size used for the test set and the data provenance: No specific test set or study data is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set is described.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does provide regarding "proof" and "acceptance":
The "proof" for this device's safety and effectiveness, as per the 510(k) process, is its substantial equivalence to existing, legally marketed predicate devices. The acceptance criteria, in this context, are implicitly that the device's design, materials, and intended use are comparable to these predicate devices.
Basis of Substantial Equivalence (from the text):
- "The I.T.S. CONNEXX Locking Tibia Nail is substantially equivalent to the Synthes, DePuy/ACE, Zimmer, Stryker, and Biopro IM Tibia Nail systems."
- The comparison likely involves:
- Intended Use: The indications for use are very similar to those of the predicate devices.
- Technology/Design Principles: It's an intramedullary rod with locking/nonlocking cross-screw fixation, a common design for such devices.
- Materials: High strength 6-4 ELI Titanium Alloy (ASTM F-136) is a standard material for orthopedic implants.
- Performance Characteristics: While not explicitly detailed, the equivalence would imply that its mechanical performance (e.g., strength, fatigue resistance) is comparable to the predicate devices, likely demonstrated through bench testing as part of the 510(k) submission (though not described in this summary).
Conclusion:
This 510(k) summary does not describe a study with explicit acceptance criteria and device performance metrics in the way one might expect for a diagnostic or AI device. Instead, it leverages the concept of substantial equivalence to predicate devices as its primary justification for safety and effectiveness. The "acceptance criteria" are met by demonstrating that the new device is sufficiently similar to already approved devices.
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K080706 p.14
| Section XII: | 510(k) Summary of Safety and EffectivenessSAFE MEDICAL DEVICES ACT OF 1990510(k) Summary |
|---|---|
| NAME OF FIRM: | JUN - 9 2008I.T.S. Implantat-Technologie-Systeme GmbH.Autal 28.Lassnitzhoehe A 8301AUSTRIA |
| 510(k) FIRM CONTACT: | Al LippincottEngineering Consulting Services, Inc.3150 E. 200th St.Prior Lake, MN 55372 |
| TRADE NAME: | CONNEXX Locking Tibia Nail |
| COMMON NAME: | Intramedullary Nail System |
| CLASSIFICATION: | Single/multiple component metallic bone fixation appliances andaccessories (see 21 CFR, Sec. 888.3040)Rod, Fixation, Intramedullary and Accessories(see 21 CFR, Sec. 888.3020) |
| DEVICE PRODUCT CODE: | HWC |
| SUBSEQUENT PRODUCT CODE: | HSB |
| SUBSTANTIALLYEQUIVALENT DEVICES | Synthes Tibial Nail System (K040762)DePuy/ACE VersaNail Tibial Nail (K032097)Synthes Cannulated Tibial Nail (K962047)Synthes Universal Tibial Nail & Unreamed Tibial Nail (K914453)BioPro Wujin #3 Tibial Nail (K002325)Zimmer Sirus Intramedullary Nail-Femoral and Tibial Nail (K043270)Stryker Interlocking Tibial Nailing System (K915435) |
| DEVICE DESCRIPTION: | The I.T.S. CONNEXX Locking Tibia Nail is a fracture fixationintramedullary rod with locking/nonlocking cross-screw fixation forrepairing long bone tibia fractures of a patient. The I.T.S. CONNEXXLocking Tibia Nail System is composed of a cannulated 9mm and 10mmdiameter nail in various lengths (255mm to 420mm in 15mm increments)and two styles of cross-screw attachments, a 4.7mm standard corticalscrew as a non-locking feature and a 4.7mm Bolt Double Thread as anon-locking feature (two thread diameters on the screw for threadengagement into the proximal and distal cortex of the tibial shaft wheninserted). A cannulated 'locking key sleeve' and 'end cap' combinationfunction to firmly fix the above two cross-screw attachments to the 9mmor 10mm nail for 'locking' the cross-screws to the tibia nail - thusmaking the entire IM rod/cross-screw assembly 'angle-stable locking'.All tibial rods and cross-screws are composed of high strength 6-4 ELITitanium Alloy to ASTM F-136. A full compliment of instrumentationis available for use with the system. |
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Proper alignment instrumentation is incorporated for proper postioning of the locking screw to screw hole in the IM rod -- along with the assistance of X-ray Fluoroscopy. The intended use of the I.T.S. CONNEXX Locking Tibia Nail is to INTENDED USE: stabilize fractures of the proximal and distal tibia and the tibial shaft in a pediatric or adult patient. Indications for use include open and closed tibial shaft fractures; certain pre and post-isthmic fractures, tibial malunions and non-unions, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, metaphyseal and epiphyseal fractures, transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, bone support, and fractures with bone loss. BASIS OF SUBSTANTIAL The I.T.S. CONNEXX Locking Tibia Nail is substantially EQIVLAENCE: equivalent to the Synthes, DePuy/ACE, Zimmer, Stryker, and Biopro IM Tibia Nail systems. SUMMARY OF SAFETY AND EFFECTIVENESS: The I.T.S. CONNEXX Locking Tibia Nail is shown to be safe and effective for use in fracture fixation of the tibia.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2008
I.T.S. Implantat-Technologie-Systeme GmbH % Engineering Consulting Services, Inc. Mr. Al Lippincott 3150 E. 200th Street Prior Lake, Minnesota 55372
Re: K080706
Trade/Device Name: CONNEXX Locking Tibia Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: II Product Code: HSB, JDS, HWC Dated: March 10, 2008 Received: March 12, 2008
Dear Mr. Lippincott:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 or unly with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF I art 807); ideeing (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Al Lippincott
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use 510(k) NUMBER: K080706 DEVICE NAME: CONNEXX Locking Tibia Nail INDICATIONS FOR USE:
Indications for use include open and closed tibial shaft fractures; certain pre and post-isthmic fractures, tibial malunions and non-unions, corrective osteotomies, pathologic fractures, pseudoarthrothis of the tibial shaft, mataphyseal and epiphyseal fractures, transverse fractures, oblique fractures, spiral fractures, segmental fractures, comminuted fractures, bone transport, and fractures with bone loss.
Prescription Use Yes AND/OR Over-The-Counter-Use
se No
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil R.P.O.sal for mam
(Division Division of General. Restorative. and Neurological Devices
510(k) Number_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Section XI
§ 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.