The intended use of the Ortho Solutions Trauma Implants for Osteosynthesis System is to draw two or more aligned bone fragments together to facilitate healing.

Ortho Solutions K-Wires, Steinman Pins, Guide Pins, Fixation Pins, & Rush Pins are indicated for use in fixation of bone fractures, for bone reconstruction, for skeletal traction in alignment of long bone fractured segments, and as guide pins & wires for insertion of other implants.

Ortho Solutions Cerclage Wire is indicated for use for bone fracture fixation. osteotomy, arthrodesis, correction of deformity, revision procedures where other treatments or devices have been unsuccessful, and bone reconstruction procedures.

Ortho Solutions Cannulated Bone Screws and Washers are indicated for use over a guide pin or wire for aligned bone fracture fixation and bone fragment fixation. Washers of matching size to the cannulated bone screw may be used in certain applications. Cannulated bone screw sizes (with optional washer) of 4.0mm. 4.5mm. 5.0mm, 6.5mm, and 8.0mm are to be used with large and long bones in the skeletal anatomy. Specific indications, which are dependent in part on the diameter of the screw include: Minimally invasive fracture/joint reconstructions: Additive osteosynthesis for complex joint fractures; Multiple-fragment joint fractures; Femoral neck and femoral head fractures; Femoral supracondylar fractures; Tibial plateau fractures; Fractures of the head of the humerus & tibia; Cooper fractures of the tibia; Fractures of radius, wrist, ankle, elbow, and shoulder: Ligament fixation of the proximal humerus: Fractures of the acetabulum and dorsal pelvic ring: Condylar fractures; Ligament avulsion injuries; Malleolar and navicular fractures; Fractures of the calcaneus and talus; Arthrodesis of the ankle joint; and Avulsion fractures.

The Ortho Solutions Trauma Implants for Osteosynthesis System is not intended for spinal use.

Device Description

The Ortho Solutions Trauma Implants for Osteosynthesis consists of general predicate type trauma implant components commonly found with large companies with orthopedic markets in the United States. These 'general trauma implant devices' consist of the following categories:

K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins, and Cerclage Wire
Cannulated Bone Screws & Washers

A brief and concise description of each system is as follows:

K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins and Cerclage Wire: These implant devices are offered in various diameters and lengths. These devices are also offered in various point configurations on one or both ends and can be partially threaded, fully threaded, smooth, or calibrated. K-Wires, Steinman Pins and Rush Pins_position and draw fractured bone together to facilitate healing. Guide Pins are used to guide other implant devices into a fractured bone site area. External Fixation Pins are driven through the skin into bone and provide position and traction of fractured bone to allow bone healing. Cerclage Wire is soft to allow a 'wrap around' of fractured bones and draw fractured bone together to facilitate healing. All K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins and Cerclage Wires are made of surgical grade 316LVM Stainless Steel to ASTM F138 and/or 6-4 Alloyed Titanium to ASTM F136. All K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins and Cerclage Wires are offered 'Sterile' to the customer.
Cannulated Bone Screws & Washers: These implant devices consist of various length cannulated cortical and cancellous screws in a 4.0mm, 4.5mm, 5.0mm, 6.5mm, and 8.0mm thread diameter size in a full, partial, reverse-cutting, and self-tapping configurations. Washers of various sizes are matched to each screw type. Associated guide pin, drills, and ancillary instrumentation is available. The cannulated screws are intended for use over a guide pin or wire for bone fracture and bone fragment fixation. All cannulated screws and washers are manufactured from high strength 6-4 Alloyed Titanium to ASTM F136. All cannulated screws and washers are offered 'sterile' to the customer.

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for the Ortho Solutions Trauma Implants for Osteosynthesis. It is a premarket notification for a medical device and therefore describes the device's indications for use and substantial equivalence to previously cleared devices, rather than presenting a study of its performance against specific acceptance criteria.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not report specific acceptance criteria or performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical properties with thresholds) for the device. Instead, it relies on demonstrating substantial equivalence to existing legally marketed predicate devices.

Acceptance Criteria (Not Explicitly Stated for this device)	Reported Device Performance (Demonstrated by Substantial Equivalence)
No explicit performance-based acceptance criteria are provided in this document. For devices like bone fixation implants, typical performance criteria would involve: - Mechanical properties: (e.g., tensile strength, torsional strength, fatigue life, bending strength, pull-out strength) meeting established ASTM or ISO standards for similar devices. - Biocompatibility: (e.g., non-toxic, non-allergenic) as per ISO 10993 standards. - Sterility assurance level (SAL). - Clinical efficacy/safety in terms of successful fracture healing, low complication rates, etc.	The device is substantially equivalent to a long list of legally marketed predicate devices in terms of: - Material: Surgical grade 316LVM Stainless Steel to ASTM F138 and/or 6-4 Alloyed Titanium to ASTM F136. - Geometry Design/Markings: Similar to predicate devices. - Indications for Use: The stated indications for individual components (K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins, Cerclage Wire, Cannulated Bone Screws & Washers) are consistent with the predicate devices. - Safety and Effectiveness: Shown to be safe and effective for use as 'sterile' and for single-use in a surgical setting, based on equivalence.

Acceptance Criteria (Not Explicitly Stated for this device)

Reported Device Performance (Demonstrated by Substantial Equivalence)

No explicit performance-based acceptance criteria are provided in this document. For devices like bone fixation implants, typical performance criteria would involve: - Mechanical properties: (e.g., tensile strength, torsional strength, fatigue life, bending strength, pull-out strength) meeting established ASTM or ISO standards for similar devices. - Biocompatibility: (e.g., non-toxic, non-allergenic) as per ISO 10993 standards. - Sterility assurance level (SAL). - Clinical efficacy/safety in terms of successful fracture healing, low complication rates, etc.

The device is substantially equivalent to a long list of legally marketed predicate devices in terms of: - Material: Surgical grade 316LVM Stainless Steel to ASTM F138 and/or 6-4 Alloyed Titanium to ASTM F136. - Geometry Design/Markings: Similar to predicate devices. - Indications for Use: The stated indications for individual components (K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins, Cerclage Wire, Cannulated Bone Screws & Washers) are consistent with the predicate devices. - Safety and Effectiveness: Shown to be safe and effective for use as 'sterile' and for single-use in a surgical setting, based on equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

This document is a 510(k) premarket notification for a Class II medical device (smooth or threaded metallic bone fixation fastener). For such devices, a clinical study with a specific test set and sample size is typically not required if substantial equivalence can be demonstrated through comparison to legally marketed predicate devices.
Therefore, no specific test set or data provenance (country of origin, retrospective/prospective) related to a clinical performance study is described in this document. The "study" implicitly involved a detailed comparison of the new device's design, materials, and indications for use against the established characteristics of numerous predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Since there was no explicit clinical or performance study with a "test set" in the traditional sense, no experts were used to establish ground truth for such a set.
The "ground truth" for substantial equivalence is based on regulatory standards and the characteristics of predicate devices already deemed safe and effective by the FDA. The review process itself involves FDA experts (e.g., within the Division of Surgical, Orthopedic and Restorative Devices).

4. Adjudication Method for the Test Set:

No adjudication method is mentioned as there was no test set requiring human interpretation or consensus. The review process is regulatory, comparing the new device to predicates based on objective criteria (materials, design, intended use).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typical for diagnostic imaging devices where human readers interpret images, often with and without AI assistance. The Ortho Solutions product is a sterile, single-use surgical implant, not a diagnostic tool where reader performance is assessed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No, a standalone performance study was not done. This concept applies to AI algorithms that operate independently. The Ortho Solutions product is a physical implant, not an algorithm. Its "performance" is inherent in its physical properties and how it functions in the body when used by a surgeon.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the established safety and effectiveness of the predicate devices. The applicant demonstrates that their device shares the same fundamental scientific technology, materials, design, and intended use as these predicates, implying it will be equally safe and effective.
For the manufacturing aspects, ground truth would also involve adherence to established material specifications (e.g., ASTM F138, ASTM F136) and Good Manufacturing Practices (GMP).

8. The Sample Size for the Training Set:

Not applicable. This device is a physical implant, not an AI model or algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As a physical implant, there is no training set or associated ground truth in the AI/machine learning sense.

Summary

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510(k) Summary of Safety and Effectiveness

KI10895

DEC 1 9 2011 ·

SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary

NAME OF FIRM:	Ortho Solutions LimitedWest Station Buisness ParkSpital RoadMaldonESSEX, CM9 6FFUnited Kingdom
510(k) FIRM CONTACT:	Al LippincottEngineering Consulting Services, Inc.3150 E. 200th St.Prior Lake, MN 55372e-mail: allippincott@msn.com
DATE:	February 15, 2011
TRADE NAME:	Ortho Solutions Trauma Implants for Osteosynthesis
COMMON NAME:	K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins,Cerclage Wires and Cannulated Bone Screws & Washers
CLASSIFICATION:	Smooth or threaded metallic bone fixation fastener(per 21CFR888.3040) – Pin, Fixation, Smooth; Pin, FixationThreaded; Screw, Fixation, Bone.
	Bone fixation cerclage (per 21CFR888.3010) – Orthopedic Wire
	Single/multiple component metallic bone fixation appliance andaccessories (per 21CFR888.3030) - Washer, Bolt Nut; Appliance,Fixation
DEVICE PRODUCT CODE:	HWC
SUBSEQUENT PRODUCT CODE:	JDW, JDQ, HTY, HTN
SUBSTANTIALLYEQUIVALENT DEVICES	K-Wires & Steinman Pins - Synvasive Technology (K961522)K-Wires & Steinman Pins - DePuy (K960385)Pins - Treu-Instrumente (K083912)Orthopedic Wire - Howmedica Osteonics (K031127)K-Wire - BioPro, Inc. (K083490)K-Wires, Steinman Pins, Calibrated Pins -Implant Resource (K002125)Rush Pin - Onyx Medical (K903261)K-Wires - Medartis AG (K092038)Orthopedic Wire - Osteo Technology (K925447)Cann. Screws & Washers - aap Implantate AG (K021233 & K080101)Cannulated Screws & Washers - I.T.S. GmbH (K060156)Cannulated Screws & Washers - Wright Medical (K100359)Cannulated Screws & Washers - Pioneer/Zimmer (K102903)Cannulated Screws - DePuy/ACE (K903810 & K903811)Cannulated Screws - Synthes (K963172)

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DEVICE DESCRIPTION:

K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins, and Cerclage Wire

2. Cannulated Bone Screws & Washers

A brief and concise description of each system is as follows:

K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins and Cerclage Wire: These implant devices are offered in various diameters and lengths. These devices are also offered in various point configurations on one or both ends and can be partially threaded, fully threaded, smooth, or calibrated. K-Wires, Steinman Pins and Rush Pins_position and draw fractured bone together to facilitate healing. Guide Pins are used to guide other implant devices into a fractured bone site area. External Fixation Pins are driven through the skin into bone and provide position and traction of fractured bone to allow bone healing. Cerclage Wire is soft to allow a 'wrap around' of fractured bones and draw fractured bone together to facilitate healing. All K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins and Cerclage Wires are made of surgical grade 316LVM Stainless Steel to ASTM F138 and/or 6-4 Alloyed Titanium to ASTM F136. All K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins and Cerclage Wires are offered 'Sterile' to the customer.
Cannulated Bone Screws & Washers: These implant devices consist of various length cannulated cortical and cancellous screws in a 4.0mm, 4.5mm, 5.0mm, 6.5mm, and 8.0mm thread diameter size in a full, partial, reverse-cutting, and self-tapping configurations. Washers of various sizes are matched to each screw type. Associated guide pin, drills, and ancillary instrumentation is available. The cannulated screws are intended for use over a guide pin or wire for bone fracture and bone fragment fixation. All cannulated screws and washers are manufactured from high strength 6-4 Alloyed Titanium to ASTM F136. All cannulated screws and washers are offered 'sterile' to the customer.

The intended use of the Ortho Solutions Trauma Implants for INTENDED USE: Osteosynthesis System of fixation device(s) is to draw two or more aligned bone fragments together to facilitate healing.

Ortho Solutions K-Wires, Steinman Pins, Guide Pins, Fixation Pins and Rush Pins are indicated for use in fixation of bone fractures, for bone reconstruction, for skeletal traction in alignment of long bone fractured segments, and as guide pins & wires for insertion of implants.

KI10895

{2}------------------------------------------------

	Ortho Solutions Cerclage Wire is indicated for use for bone fracturefixation, osteotomy, arthrodesis, correction of deformity, revisionprocedures where other treatments or devices have been unsuccessful,and bone reconstruction procedures.
	Ortho Solutions Cannulated Bone Screws and Washers are indicatedfor use over a guide pin or wire for aligned bone fracture fixation andbone fragment fixation. Washers of matching size to the cannulatedbone screw may be used in certain applications.Cannulated bone screw sizes (with optional washer) of 4.0mm, 4.5mm,5.0mm. 6.5mm and 8.0mm are to be used with large and long bones inthe skeletal anatomy. Specific indications, which are dependent in parton the diameter of the screw include: Minimally invasive fracture/jointreconstructions; Additive osteosynthesis for complex joint fractures;Multiple-fragment joint fractures; Femoral neck and femoral headfractures; Femoral supracondylar fractures; Tibial plateau fractures;Fractures of the head of the humerus & tibia; Cooper fractures of thetibia; Fractures of radius, wrist, ankle, elbow, and shoulder; Ligamentfixation of the proximal humerus; Fractures of the acetabulum anddorsal pelvic ring; Condylar fractures; Ligament avulsion injuries;Malleolar and navicular fractures; Fractures of the calcaneus and talus;Arthrodesis of the ankle joint; and Avulsion fractures.
	The Ortho Solutions Trauma Implants for Osteosynthesis Systemis not intended for spinal use.
EQUIVALENCE:	The Ortho Solutions Trauma Implants for Osteosynthesis issubstantially equivalent to predicate systems from many orthopediccompanies (as listed).
SUMMARY OF TECH-NOLOGICAL CHAR-ACTERISTICS	The Ortho Solutions Trauma Implants for Osteosynthesis are similar inMaterial, Geometry Design/Markings, and Indications to manypredicate systems currently sold in the U.S. market.
SUMMARY OF SAFETYAND EFFECTIVENESS:	The Ortho Solutions Trauma Implants for Osteosynthesis is shown tobe safe and effective for use as 'sterile' and for single-use in a surgicalsetting.

110845

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Image /page/3/Picture/1 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Mail Center - WO66-G609, Silver Spring, MD 20993-0002. The text is left-aligned and uses a serif font.

DEC 1 9 2011

Ortho Solutions, LTD % Engineering Consulting Services, Inc. % Mr. Al Lippincott 3150 E. 200th Street Prior Lake, Minnesota 55372

Re: K110895

Trade/Device Name: Ortho Solutions Trauma Implants for Osteosynthesis Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, HTY, JDW, HTN, JDQ Dated: December 15, 2011 Received: December 16, 2011

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. 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

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Page 2 - Mr. Al Lippincott

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 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,

yours,

Melkerson

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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Indications for Use

510(k) NUMBER: K110895 DEVICE NAME: O Ortho Solutions Trauma Implants for Osteosynthesis INDICATIONS FOR USE:

The intended use of the Ortho Solutions Trauma Implants for Osteosynthesis System is to draw two or more aligned bone fragments together to facilitate healing.

The Ortho Solutions Trauma Implants for Osteosynthesis System is not intended for spinal use.

Prescription Use X __ AND/OR ...... (Per 21 CFR 801 Subpart D)

Over-The-Counter-Use

(21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

fir Mock Melkerson

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

//0895

p. lof l

Regulation Number and Section

§ 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.