Stabilization/fixation of:
- o Long bone fractures in tibia and femur
- o Fractures of pelvis and ankle
- Peri-articular and intra-articular fractures of knee and ankle o
. Joint arthrodesis
Non-unions and mal-unions .
Osteotomies

Device Description

The Renovis T 710 Large External Fixation System is an external fixation device consisting of bone pins, connecting rods, clamps, posts and related accessories used for the management of bone fractures and reconstructive orthopedic surgery. The device is a modular system designed to provide a broad range of frame construction options. The connecting rods are made from unidirectional carbon fiber reinforced epoxy. Pins and clamp components are made from materials conforming to ASTM F136 and ASTM F138.

AI/ML Overview

This 510(k) summary describes a traditional medical device (external fixation system), not an AI/ML powered device. As such, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like accuracy, sensitivity, specificity, and MRMC studies) are not applicable here.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that their device is as safe and effective as devices already legally marketed. The "proof" for this comes from comparing the new device's intended use, design principles, materials, and overall dimensions to those of predicate devices, along with engineering analysis.

Here's how the provided information relates to your request, interpreted for a traditional medical device:

A table of acceptance criteria and the reported device performance:
This document does not present acceptance criteria in terms of quantitative performance metrics (e.g., accuracy, sensitivity) for the device's function, nor does it report such performance.
Instead, the "acceptance criteria" implicitly revolve around demonstrating that the new device is substantially equivalent to existing predicate devices. The "reported device performance" in this context refers to the characteristics of the device itself (materials, design, intended use) that are compared to those of the predicate devices.

Characteristic	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Renovis T 710)
Intended Use	Must be the same as or very similar to predicate devices.	- Stabilization/fixation of long bone fractures (tibia, femur), pelvis, ankle fractures, peri-articular and intra-articular fractures (knee, ankle) - Joint arthrodesis - Non-unions and mal-unions - Osteotomies (Stated to be the "same intended use" as predicates)
Design Principles	Must be the same as or very similar to predicate devices.	- Modular system for broad range of frame construction options - Consists of bone pins, connecting rods, clamps, posts, accessories - Creates rigid construct (frame) to stabilize instabilities - Implantable bone pins (titanium alloy or stainless steel, distally or centrally threaded) (Stated to incorporate "the same basic design" and "same operating principle" as predicates)
Materials	Must use the same or very similar materials as predicate devices, conforming to relevant standards (e.g., ASTM F136, ASTM F138).	- Connecting rods: unidirectional carbon fiber reinforced epoxy - Pins and clamp components: materials conforming to ASTM F136 and ASTM F138 - Implantable bone pins: titanium alloy or stainless steel (Stated to incorporate "the same or very similar materials" as predicates)
Overall Dimensions	Must have similar overall dimensions or variations that do not raise new safety/efficacy concerns compared to predicate devices.	Not explicitly detailed but implied by the statement: "The intended use, design principles, materials and overall dimensions of the subject and predicate devices are substantially the same." Differences in technological characteristics "do not raise new issues of safety or efficacy."
Sterilization & Packaging	Must use similar or same sterilization and packaging methods as predicate devices.	- Similar packaging - Sterilized using the same materials and processes (Stated in comparison to predicates)
Safety & Efficacy Differences	Any differences in technological characteristics must not raise new issues of safety or efficacy.	"Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy." "Data are provided to demonstrate substantial equivalence including detailed engineering analysis of the subject and predicate designs." (This is the "study" proving it meets the implicit criterion).

Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML model for this type of medical device submission. The evaluation is based on engineering analysis and comparison to predicate devices, not on data analysis for a diagnostic or predictive algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not relevant here. The "ground truth" equivalent would be established medical knowledge and regulatory standards for mechanical devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set where adjudication is needed.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a traditional mechanical medical device, not an AI-assisted diagnostic or therapeutic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device with no algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML sense. The "ground truth" for this submission is established through:
- Regulatory Precedent: The existence of legally marketed predicate devices with known safety and effectiveness.
- Engineering Principles: Sound biomechanical and material science principles ensuring the device functions as intended.
- Standardized Testing: Implicitly, the components meet industry standards (e.g., ASTM F136, ASTM F138).
- Clinical Experience: The long-standing use and understanding of external fixation systems in orthopedic surgery.
The sample size for the training set: Not applicable. There is no training set for a mechanical device.
How the ground truth for the training set was established: Not applicable. No training set for a mechanical device.

Study Proving Device Meets Acceptance Criteria (Substantial Equivalence Documentation):

The document states: "Data are provided to demonstrate substantial equivalence including detailed engineering analysis of the subject and predicate designs."

This "detailed engineering analysis" serves as the "study" proving the device meets the implicit acceptance criteria for substantial equivalence. It would involve:

Material Characterization: Testing of the carbon fiber, titanium alloy, and stainless steel to ensure they meet the specified ASTM standards and have properties comparable to predicate devices.
Mechanical Testing:
- Static Loading Tests: Evaluating the strength and stiffness of individual components (pins, rods, clamps) and the assembled frame under various loads (e.g., compression, tension, bending, torsion) to simulate physiological forces.
- Fatigue Testing: Assessing the durability of components and the frame under cyclical loading to simulate long-term use and ensure they do not fail prematurely.
- Pin Pull-out Strength: Measuring the force required to dislodge pins from bone surrogates, ensuring adequate fixation.
- Clamp Slippage Resistance: Verifying that clamps maintain their position on rods under load.
Dimensional Conformance: Measuring components to ensure they meet design specifications and are compatible with surgical techniques and existing predicate systems where relevant.
Biocompatibility Testing: (Though not explicitly mentioned for this specific device in the summary, it's a standard requirement for all implantable components unless predicate materials have established biocompatibility).
Sterilization Validation: Ensuring the chosen sterilization method is effective and doesn't degrade materials.

The results of these engineering analyses would be compared directly to the known characteristics and performance of the specified predicate devices (Howmedica Hoffmann Fixation Pin System, Apex Fixation Pins, Hoffmann II External Fixation System, Synthes Adjustable Large Fixator System, and TransFx External Fixation System) to demonstrate that the Renovis T 710 "does not raise new issues of safety or efficacy."

Summary

{0}------------------------------------------------

510(k) Summary

i0965

Renovis T 710 Large Externa! Fixation System

INTENDED USE

The Renovis T 710 Large External Fixation System is indicated for the following:

Stabilization/fixation of:
- o Long bone fractures in tibia and femur
- o Fractures of pelvis and ankle
- Peri-articular and intra-articular fractures of knee and ankle o
. Joint arthrodesis
Non-unions and mal-unions .
Osteotomies

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

The Renovis T 710 Large External Fixation System is substantially equivalent in indications and design principles to the following predicate devices each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:

Howmedica Hoffmann Fixation Pin System from Howmedica Corp. (now Stryker Corporation). K861766;

Apex Fixation Pins from Howmedica Osteonics Corp. (now Stryker Corporation), K01136; Hoffmann II External Fixation System from Howmedica Corp. (now Stryker Corporation), K952730:

Synthes Adjustable Large Fixator System from Synthes (USA), K010344; and TransFx External Fixation System from Immedica, Inc. (now Zimmer, Inc.), K984357.

The intended use, design principles, materials and overall dimensions of the subject and predicate devices are substantially the same. Both the subject and predicate devices are intended to stabilize traumatic or surgically created instabilities of the pelvis and lower extremities through the use of implantable pins and external components in a variety of sizes. These components are used to create a rigid construct (frame) suitable to the individual needs of the patient. As with one or more of the predicate devices, the implantable bone pins are made from titanium alloy or stainless steel and are distally threaded or centrally threaded to enable unilateral or bilateral frame construction.

$p, l*{0} \beta*{2}$

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KU0965

510(k) Summary

Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy.

Data are provided to demonstrate substantial equivalence including detailed engineering analysis of the subject and predicate designs.

Overall, Renovis T 710 Large External Fixation System has the following similarities to the predicate devices:

. has the same intended use,
uses the same operating principle, .
incorporates the same basic design, .
incorporates the same or very similar materials, and .
has similar packaging and is sterilized using the same materials and processes .

p. 2 of 2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with stylized lines representing its wings and body.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 1 1 2011

Renovis Surgical Technologies, LLC % Paxmed International, LLC David Collette, M.D. 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K110965

Trade/Device Name: Renovis T 710 Large External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: April 6, 2011 Received: April 6, 2011

Dear Dr. Collette:

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

{3}------------------------------------------------

Page 2 - David Collette, M.D.

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

$\underset{k}{B}$ R. to

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Summary

Indications for Use 110965

510(k) Number:

Device Name:

Renovis T 710 Large External Fixation System

Indications for Use:

The Renovis T 710 Large External Fixation System is indicated for the following:

Stabilization/fixation of:
- 0 Long bone fractures in tibia and femur
- o Fractures of pelvis and ankle
- Peri-articular and intra-articular fractures of knee and ankle o
Joint arthrodesis .
Non-unions and mal-unions .
. Osteotomies

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Page 1 of |

Apr M. Mulkerson

(Division Sign-Oft) (Division Sign-Old), Orthopedic, Division of Surgions
and Restorative Devices

Image /page/4/Picture/22 description: The image shows the text "510(k) Number" followed by "K110965". The text is written in a clear, legible font. The number is likely a reference to a medical device clearance from the FDA.

Page 16 af 310

Regulation Number and Section

§ 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.