The Ortho Solutions Limited Oxford Ankle Fusion Nail (AFN) System is a tibiotalocalcaneal (TTC) solid fusion system that has been developed for the following indications:

Failed ankle replacement
Arthritis of ankle and subtalar joint
Correcting neuromuscular imbalance of hindfoot, where bone fusion is required
Revision of failed ankle and/or subtalar fusion
Revision of failed Tibiotalocalcaneal (TTC) fusion
Talar Avascular Necrosis (AVN)
Charcot
Trauma
Neuroarthropathy
Pseudoarthrosis
Rheumatoid arthritis

Device Description

The Ortho Solutions Oxford Ankle Fusion Nail (AFN) System is composed of three(3) diameter (10, 11 & 12mm) sizes by two(2) lengths (150 & 180mm) as a straight nail, cannulated, to accept a 3.9mm Guide Pin. The cannulated nail is inserted through a dorsal heel incision over a guide wire using x-ray fluoroscopy within the ankle boney anatomy and distal tibia medullary canal. The guidewire is used to achieve adequate positioning. A Revision Nail in all sizes is also offered where the angled transverse hole is removed. A low-profile head 5.0mm Cortical Transverse Bone Screw (in 26 lengths of 20 - 115mm in 2 & 5mm increments) is used for proximal and distal multiple 'cross-screw' fixation after compression of the ankle joint space. Dynamization Slots(2) are located at the Proximal End of the nail. Also offered is a Standard and Locking End Cap for closing the distal end of the nail. The Locking End Cap rests and locks against the most distal Transverse 5.0mm Cortical Screw. For completion of long bone fractures, End Caps in 3 lengths (+0, +5 & +10) and in 3 diameters (10, 11 & 12mm) are used for distal IM Nail Length Extension as necessary. As well, all End Caps seal the end of the nail to avoid ingrowth of tissues. All bone hole preparation and bone screw insertion is with the assistance of intra-operative x-ray fluoroscopy. All implant components are offered 'Sterile' for Single Use. With the Intramedullary Nail inserted into the ankle bone, an instrument 'Targeting Arm' with alignment holes is attached to the distal end of the nail. This external Targeting Arm allows proper orientation, preparation, and alignment of the proper cannula for transverse and angled drilling of bone screw holes into the nail and ankle anatomy cortical and cancellous bone. The bone hole preparation is for proper alignment to the referenced transverse and angled holes within the Intramedullary Nail for insertion of Transverse 5.0mm Cortical Bone Screws. All implant components are made from 6-4 Alloyed Titanium material to ASTM F 136 and are anodized with a Type II surface preparation. The IM Nail, End Cap and Transverse Screws may be removed when long bone fracture(s) are healed or the ankle joint space is fused. A full complement of instrumentation (external Targeting Arm Main Jig. guide wire/pins, drill guides/sleeves, cannulated tissue protector sleeves, depth gauge, reamers, reaming rod, drills, drivers, cannulated guide tube & trocar, etc.) is available with the system. A 'sterile single use' disposable pack is available encompassing a guide pin, guide rod, drills, reamer, reaming rod and exchange tube. A implant extraction/removal instrumentation set is also made available.

AI/ML Overview

The provided text is a 510(k) summary for the Oxford Ankle Fusion Nail (AFN) System. This document describes a medical device seeking market clearance based on substantial equivalence to previously approved devices, rather than comprehensive clinical studies proving independent acceptance criteria and performance metrics.

Therefore, the information listed below regarding "acceptance criteria" and various study details is largely not applicable (N/A) in the context of a 510(k) submission for a device like an intramedullary nail. The FDA's 510(k) pathway focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, not on establishing novel performance benchmarks through extensive clinical trials.

The summary emphasizes "equivalence" and "similarity in material, geometry design/markings, and indications" to predicate systems. The "Summary of Safety and Effectiveness" simply states the device is "shown to be safe and effective for use as 'sterile' and for single-use in a surgical setting," which typically refers to non-clinical testing (e.g., biocompatibility, sterilization validation, mechanical testing) and comparison to predicate devices, not specific performance criteria from a clinical study.

Here's an attempt to populate the requested table and sections based on the provided text, indicating "N/A" where the information is not present or not relevant to a 510(k) for this type of device:

Acceptance Criteria and Device Performance Study Analysis

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated in typical 510(k) for this device type)	Reported Device Performance (Implied by substantial equivalence)
Mechanical Performance: (e.g., strength, fatigue, torsional resistance) - Criteria not explicitly defined in this summary but assumed to meet standards comparable to predicate devices.	Material: 6-4 Alloyed Titanium (ASTM F 136), anodized.
	Geometry: Three diameters (10, 11, 12mm), two lengths (150, 180mm), cannulated. Low-profile head 5.0mm Cortical Transverse Bone Screw.
	Functionality: Provides tibiotalocalcaneal (TTC) solid fusion. Allows for proximal and distal multiple 'cross-screw' fixation. Includes Dynamization Slots. Designed for removal after healing.
Biocompatibility: (e.g., non-toxic, non-allergenic) - Criteria not explicitly defined in this summary but assumed to meet standards comparable to predicate devices and material specifications.	All implant components made from 6-4 Alloyed Titanium material to ASTM F 136 and are anodized with a Type II surface preparation.
Sterility: (e.g., validated sterilization methods) - Criteria not explicitly defined in this summary but assumed to meet standards.	All implant components are offered 'Sterile' for Single Use. A 'sterile single use' disposable pack is available.
Clinical Performance: (e.g., fusion rates, complication rates) - Not typically required for 510(k) of this device type; inferred through equivalence to predicate devices.	"The Ortho Solutions Limited Oxford Ankle Fusion Nail (AFN) System is shown to be safe and effective for use as 'sterile' and for single-use in a surgical setting." (This statement is a high-level summary, not a report of specific clinical outcomes or statistical performance metrics).
Intended Use: Device performs as intended for specified indications.	Intended Use matches predicate devices and supports various conditions requiring tibiotalocalcaneal (TTC) solid fusion (e.g., failed ankle replacement, arthritis, trauma, Charcot, etc.).

Note: For devices cleared through the 510(k) pathway, detailed, statistically significant acceptance criteria and performance data from clinical studies are often not provided in the summary document. Instead, the focus is on demonstrating that the new device is "substantially equivalent" to existing, legally marketed predicate devices. This typically involves non-clinical (bench) testing, material characterization, and comparison of design and indications for use.

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): N/A (No clinical test set data from a study to prove acceptance criteria is described in this 510(k) summary.)
Data Provenance: N/A (As no clinical test set is described, data provenance for such a set is also not applicable.)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A (No human-adjudicated test set is described. The 510(k) process for this device type typically relies on engineering and material standards, and comparison to predicate devices, rather than expert-established ground truth from patient data for performance evaluation.)

4. Adjudication method for the test set

N/A (No test set requiring adjudication is described.)

5. 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

N/A (This device is an intramedullary nail, not an AI-powered diagnostic or assistive device. Therefore, MRMC studies involving human readers and AI assistance are not relevant.)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A (This device is a physical implant, not a software algorithm.)

7. The type of ground truth used

N/A (For this type of 510(k), "ground truth" in the sense of clinical outcomes or expert labels is generally not derived directly from a new clinical study. Instead, the ground truth is often established by the successful performance and safety record of the predicate devices that the new device is compared against, along with non-clinical testing verifying material properties and mechanical performance.)

8. The sample size for the training set

N/A (No training set is mentioned or applicable as this is not a machine learning/AI device.)

9. How the ground truth for the training set was established

N/A (No training set is mentioned or applicable.)

Summary

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510(k) Summary of Safety and Effectiveness

SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary

SAFE MEDICAL DEVICES ACT OF 1990

510(k) Summary

SEP 14 2012

NAME OF FIRM:	Ortho Solutions LimitedWest Station Business ParkSpital RoadMaldonESSEX, CM9 6FFUnited Kingdom
510(k) FIRM CONTACT:	Al LippincottEngineering Consulting Services, Inc.3150 E. 200 th St.Prior Lake, MN 55372Tel. No. 952-492-5858e-mail: allippincott@msn.com
DATE:	May 20, 2012
TRADE NAME:	Oxford Ankle Fusion Nail (AFN) System.
COMMON NAME:	Intramedullary Nail
CLASSIFICATION:	Intramedullary fixation rod ( see 21CFR, Sec. 888.3020 )
	Single/Multiple component metallic bone fixation appliances andaccessories ( see 21CFR, Sec. 888.3030 ).
DEVICE PRODUCT CODE:	HSB
SUBSTANTIALLYEQUIVALENT DEVICES	DePuyACE - VersaNail TM TTC Fusion Nail (K023115 & K003797)Smith & Nephew - TRIGEN TM Hindfoot Fusion Nail (K043052)Stryker - T2 ® TM Ankle Arthrodesis Nail (K051590, K020384)Biomet - Phoenix TM Nail System (K091976, K081243)Wright Medical - VALOR ® TM Ankle Fusion Nail (K110552 &K090857)Integra - PANTA ® Arthrodesis Nail (K091788, K050882)
DEVICE DESCRIPTION:	The Ortho Solutions Oxford Ankle Fusion Nail (AFN) System iscomposed of three(3) diameter (10, 11 & 12mm) sizes by two(2)lengths (150 & 180mm) as a straight nail, cannulated, to accept a3.9mm Guide Pin. The cannulated nail is inserted through a dorsalheel incision over a guide wire using x-ray fluoroscopy within theankle boney anatomy and distal tibia medullary canal. The guidewireis used to achieve adequate positioning. A Revision Nail in all sizes isalso offered where the angled transverse hole is removed.

. s

SEP

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DEVICE DESCRIPTION CONTINUED:

A low-profile head 5.0mm Cortical Transverse Bone Screw (in 26 lengths of 20 - 115mm in 2 & 5mm increments) is used for proximal and distal multiple 'cross-screw' fixation after compression of the ankle joint space. Dynamization Slots(2) are located at the Proximal End of the nail. Also offered is a Standard and Locking End Cap for closing the distal end of the nail. The Locking End Cap rests and locks against the most distal Transverse 5.0mm Cortical Screw. For completion of long bone fractures, End Caps in 3 lengths (+0, +5 & +10) and in 3 diameters (10, 11 & 12mm) are used for distal IM Nail Length Extension as necessary. As well, all End Caps seal the end of the nail to avoid ingrowth of tissues. All bone hole preparation and bone screw insertion is with the assistance of intra-operative x-ray fluoroscopy. All implant components are offered 'Sterile' for Single Use.

With the Intramedullary Nail inserted into the ankle bone, an instrument 'Targeting Arm' with alignment holes is attached to the distal end of the nail. This external Targeting Arm allows proper orientation, preparation, and alignment of the proper cannula for transverse and angled drilling of bone screw holes into the nail and ankle anatomy cortical and cancellous bone. The bone hole preparation is for proper alignment to the referenced transverse and angled holes within the Intramedullary Nail for insertion of Transverse 5.0mm Cortical Bone Screws.

All implant components are made from 6-4 Alloyed Titanium material to ASTM F 136 and are anodized with a Type II surface perparation.

The IM Nail, End Cap and Transverse Screws may be removed when long bone fracture(s) are healed or the ankle joint space is fused.

A full complement of instrumentation (external Targeting Arm Main Jig. guide wire/pins, drill guides/sleeves, cannulated tissue protector sleeves, depth gauge, reamers, reaming rod, drills, drivers, cannulated guide tube & trocar, etc.) is available with the system. A 'sterile single use' disposable pack is available encompassing a guide pin, guide rod, drills, reamer, reaming rod and exchange tube. A implant extraction/removal instrumentation set is also made available.

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INTENDED USE:	The Ortho Solutions Limited Oxford Ankle Fusion Nail (AFN)System is a tibiotalocalcaneal (TTC) solid fusion system that has beendeveloped for the following indications:
	➤ Failed ankle replacement➤ Arthritis of ankle and subtalar joint
	➤ Correcting neuromuscular imbalance of hindfoot, where bone fusion isrequired
	➤ Revision of failed ankle and/or subtalar fusion
	➤ Revision of failed Tibiotalocalcaneal (TTC) fusion
	➤ Talar Avascular Necrosis (AVN)
	➤ Charcot
	➤ Trauma
	➤ Neuroarthropathy
	➤ Pseudoarthrosis
	➤ Rheumatoid arthritis
EQUIVALENCE:	The Ortho Solutions Limited Oxford Ankle Fusion Nail (AFN) Systemis substantially equivalent(SE) to predicate systems from manyorthopedic companies (as listed).
SUMMARY OF TECH-NOLOGICAL CHAR-ACTERISTICS	The Ortho Solutions Limited Oxford Ankle Fusion Nail (AFN) Systemis Similar in Material, Geometry Design/Markings, and Indications tomany predicate systems currently sold in the U.S. market.
SUMMARY OF SAFETYAND EFFECTIVENESS:	The Ortho Solutions Limited Oxford Ankle Fusion Nail (AFN) Systemis shown to be safe and effective for use as 'sterile' and for single-usein a surgical setting.

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

SEP 14 2012

Ortho Solutions Limited % Engineering Consulting Services % Mr. Al Lippincott 3150 E. 200th St. Prior Lake, Minnesota 55372

Re: K121575

Trade/Device Name: Oxford Ankle Fusion Nail (AFN) System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: July 31, 2012 Received: August 17, 2012

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Al Lippincott

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,

for

Nuc

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:

DEVICE NAME: Oxford Ankle Fusion Nail (AFN) System

The Ortho Solutions Limited Oxford Ankle Fusion Nail (AFN) System is a tibiotalocalcaneal (TTC) solid fusion system that has been developed for the following indications:

Failed ankle replacement A
Arthritis of ankle and subtalar joint A
Correcting neuromuscular imbalance of hindfoot, where bone fusion is required A
Revision of failed ankle and/or subtalar fusion A
Revision of failed Tibiotalocalcaneal (TTC) fusion A
Talar Avascular Necrosis (AFN) A
A Charcot
A Trauma
A Neuroarthropathy
Pseudoarthrosis A
Rheumatoid arthritis

XXXXX Prescription Use

Over-The-Counter-Use

(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)

AND/OR

Asuf

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

510(k) Number K121575

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.