Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic or degenerative arthritis.

The ankle prosthesis is additionally indicated for patients with a failed previous ankle surgery.

CAUTION: The ankle prosthesis is intended for cemented use only.

Device Description

The Topez prosthesis is a total ankle joint replacement medical device. It is a semiconstrained, cemented prosthesis. It is intended to be an equivalent product to the DePuy's FDA-cleared "Agility" model, with the same indications for use.

Components: Listed below are the components comprising the Topez ankle prosthesis assembly.

1. Tibial-side replacement (tibial platform): This is a titanium (Ti-6A1-4V, ELI) structural component that holds and secures the Ultra High Molecular Weight Polyethylene (UHMWPE: GUR 1020, ASTM F648) component and interfaces with the Tibial Stem Assembly (both described below)
1. UHMWPE: This is a concave component that replaces the physiological distal end of the tibia. It is one of the two major bearing surfaces in the ankle joint replacement system. The UHMWPE snap-locks within a tibial platform using a design similar to knee replacement systems.
1. Tibial Stem Assembly: This is a titanium (Ti-6Al-4V, ELI) anchor-interface by which the tibial platform component is secured to the tibia. It consists of 4 titanium cylinders that are screwed together to form a long stem up within the center of the tibia. There are four components to be inserted through a small anterior incision in the ankle, screwed together and then pushed up into the center of the drilled tibia. The 4-stem assembly is finally secured to the tibial platform with a Morse taper lock system that is common with joint implants.
1. Talar-side replacement (talar platform): This is a convex Cobalt-Chrome (Co-Cr-Mo, ASTM F1537) bearing surface on the talar side of the ankle joint. In concert with the UHMWPE, it forms the sliding-rotating joint interface of the ankle joint. It serves the second function of providing the interface-anchor to the talus.
1. Talar Stem: This is a titanium (Ti-6Al-4V, ELI) anchor-interface by which the talar platform component is secured to the talus. The Talar Stem is attached to the Talar platform with a Morse taper lock system that is common with joint implants.

The Topez prosthesis is comprised entirely of materials now used for other implant products. The Topez ankle is intended to be used with a tibial anchor that is larger than those that are typically seen with ankle prostheses. The Topez ankle utilizes a Foot-Leg holder assembly with jigs and fixtures intended to assist the surgeon with an accurate and simple prosthesis installation tool-kit.

AI/ML Overview

The provided document is a 510(k) summary for the Topez Total Ankle Replacement device. It describes the device, its indications for use, and comparisons to a predicate device. The document does not include information about clinical studies with human participants, expert review processes, or AI/software performance. The device is a physical implant, not a software or AI-driven diagnostic tool, so many of the requested categories (like "number of experts," "adjudication method," "MRMC comparative effectiveness study," or "standalone performance") are not applicable or relevant to this type of device submission.

The acceptance criteria and device performance are based on non-clinical data, primarily mechanical and material testing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Criteria	Acceptance Criteria	Reported Device Performance
Risk Management following ISO 14971	Acceptable and mitigated potential hazards (supported by FEA and FMEA)	PASSES
Structural materials meet ASTM standards: Cobalt-Chromium-Molybdenum	ASTM F1537	Meets standard
Structural materials meet ASTM standards: Titanium, Ti-6A1-4V ELI	ASTM F136	Meets standard
Structural materials meet ASTM standards: UHMWPE, GUR1020	ASTM F648	Meets standard
Test 1: Determining the Contact Surface Area and Stresses of Articulating Surfaces	Not explicitly stated beyond "reduced material stresses" compared to predicate, but passed	PASSES
Test 2: Determining the Constraint Characteristics	Not explicitly stated	PASSES
Test 3: Determining the Disassembly Strength of Tibial Tray and UHMPWE Insert (with and without Joint Reaction Force)	Not explicitly stated	PASSES
Test 4: Test Protocol for Determining the Fatigue Strength of Tibial Stems	Not explicitly stated	PASSES
Test 5: Test Protocol for Disassembly Strength of a Calcaneal Stem	Not explicitly stated	PASSES
Test 6: Determining the Assembly/Disassembly Strength of the Tibial Stem	Not explicitly stated	PASSES

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

The document does not detail specific sample sizes for each mechanical test. The tests are non-clinical (laboratory/bench testing) and therefore do not involve patient data or human participants. The data provenance is laboratory testing conducted by the manufacturer, Topez Orthopedics, Inc.

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

Not applicable. This device is a physical implant, and its performance is evaluated through material and mechanical testing, not by expert interpretation of data like images.

4. Adjudication method for the test set

Not applicable. This is a physical device undergoing mechanical property testing.

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

Not applicable. This is a physical implant, not a software or AI-assisted diagnostic device.

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

Not applicable. This is a physical implant.

7. The type of ground truth used

The "ground truth" for this medical device's performance is established through adherence to ASTM standards for materials and validated mechanical testing protocols. The "PASSES" for each test indicate that the device met pre-defined engineering and material specifications, which serve as the ground truth for its physical and mechanical properties.

8. The sample size for the training set

Not applicable. The device is a physical product, not an AI model.

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

Not applicable. The device is a physical product, not an AI model.

Summary

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K051023

NOV 1 5 2005

Summary Page 1 of 8

510(k) Summary

Topez Orthopedics, Inc. 4701 Quail Creek Lane Boulder, CO 80301 303-530-0637

Lewis Ward Consultant

Prepared 10-20-05 L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 303-530-3279 303-530-4774 Fax

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INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Topez Total Ankle Replacement

Indications for Use:

The ankle prosthesis is additionally indicated for patients with a failed previous ankle surgery.

CAUTION: The ankle prosthesis is intended for cemented use only.

Prescription Use X______________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)

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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405 1027

Summary Page 3 of 8

Device: Ankle Prosthesis

Common Name: Ankle prothesis

SE Predicate: DePuy Inc. Agility Ankle K020541 888.3110

Device Description:

Summary: The Topez prosthesis is a total ankle joint replacement medical device. It is a semiconstrained, cemented prosthesis. It is intended to be an equivalent product to the DePuy's FDA-cleared "Agility" model, with the same indications for use.

Components: Listed below are the components comprising the Topez ankle prosthesis assembly.

1. Tibial-side replacement (tibial platform): This is a titanium (Ti-6A1-4V, ELI) structural component that holds and secures the Ultra High Molecular Weight Polyethylene (UHMWPE: GUR 1020, ASTM F648) component and interfaces with the Tibial Stem Assembly (both described below)
1. UHMWPE: This is a concave component that replaces the physiological distal end of the tibia. It is one of the two major bearing surfaces in the ankle joint replacement system. The UHMWPE snap-locks within a tibial platform using a design similar to knee replacement systems.
1. Tibial Stem Assembly: This is a titanium (Ti-6Al-4V, ELI) anchor-interface by which the tibial platform component is secured to the tibia. It consists of 4 titanium cylinders that are screwed together to form a long stem up within the center of the tibia. There are four components to be inserted through a small anterior incision in the ankle, screwed together and then pushed up into the center of the drilled tibia. The 4-stem assembly is finally secured to the tibial platform with a Morse taper lock system that is common with joint implants.
1. Talar-side replacement (talar platform): This is a convex Cobalt-Chrome (Co-Cr-Mo, ASTM F1537) bearing surface on the talar side of the ankle joint. In concert with the UHMWPE, it forms the sliding-rotating joint interface of the ankle joint. It serves the second function of providing the interface-anchor to the talus.
1. Talar Stem: This is a titanium (Ti-6Al-4V, ELI) anchor-interface by which the talar platform component is secured to the talus. The Talar Stem is attached to the Talar platform with a Morse taper lock system that is common with joint implants.

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K051023

Comparative Information

				Controller Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Chil
Summary
				Page 4 of 8

Feature	DePuy, Inc. - Agility	Topez Orthopedics, Inc.
Indications for Use	Total ankle arthroplasty isintended to give a patientlimited mobility to reducingpain, restoring alignment andreplacing the flexion andextension movement in theankle joint. Total anklearthroplasty is indicated forpatients with ankle jointsdamaged by severerheumatoid, post-traumatic ordegenerative arthritis. Theankle prosthesis is additionallyindicated for patients with afailed previous ankle surgery.Caution: The ankle prosthesisis intended for cemented useonly.	Total ankle arthroplasty isintended to give a patientlimited mobility to reducingpain, restoring alignment andreplacing the flexion andextension movement in theankle joint. Total anklearthroplasty is indicated forpatients with ankle jointsdamaged by severerheumatoid, post-traumatic ordegenerative arthritis. Theankle prosthesis is additionallyindicated for patients with afailed previous ankle surgery.Caution: The ankle prosthesisis intended for cemented useonly.
Classification	888.3110, Class II, Orthopedic87 HSN	888.3110, Class II, Orthopedic87 HSN
510(k) Number	K020541	K051023
Description	ModularSemi-ConstrainedTotal Ankle Replacement- limited patientmobility- replaces flexion andextension of anklejointAlternative to ankle fusionImitates structure andmovement of the natural anklejointNormal alignment duringstance phase	ModularSemi-ConstrainedTotal Ankle Replacement- limited patientmobility- replaces flexion andextension of anklejointAlternative to ankle fusionImitates structure andmovement of the natural anklejoint.Normal alignment duringstance phase
	DePuy, Inc. - Agility	Topez Orthopedics, Inc.
	Comfortable movement duringwalking cycle - 60 degrees ofrotation	Comfortable movement duringwalking cycle - 50 degrees ofrotation
	Broad base tibial component	Broad base tibial component
	Proper sizing:Multiple sizes - 6 sizes	Proper sizing:Multiple sizes - 6 sizes
	Materials:Tibia – Ultra High MolecularWeight PolyethyleneBase Plate Tray - titaniumTalar – cobalt chromium alloy	Materials:Tibia – Ultra High MolecularWeight PolyethyleneBase Plate Tray - titaniumTalar - cobalt chromium alloy
	Broad base tibial components	Broad base tibial components
	Tapered talar component	Tapered talar component
	Accessory:Cutting jigClass I	Accessory:Cutting jigClass I
	Tool KitClass I	Tool KitClass I
	Gas Plasma Sterilization	Gamma Sterilization
	DePuy Training Prerequisite	Topez Training Prerequisite
Coated	Porous coated distal surfaceand fin talar components	Plasma spray coated distaltalar surface, proximal tibialsurface, tibial stem & talarstem
Contact Area
Talus & UHMWPE Size 1	0.209 sq. in.	0.569 sq. in.
Size 2	0.271	0.718
Size 3	0.296	0.884
Size 4	0.41	1.068
Size 5	0.558	1.268
Size 6	0.767	1.486
	DePuy, Inc. - Agility	Topez Orthopedics, Inc.
Contact Stresses at 5 BWTalus & UHMWPE(Calculated by F/A or
5BW/Contact Area)
Size 1	3899 psi	1432 psi
Size 2	3007 psi	1135 psi
Size 3	2753 psi	922 psi
Size 4	1988 psi	763 psi
Size 5	1461 psi	643 psi
Size 6	1063 psi	548 psi

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Similarities and Differences

Indications for Use are the same for total ankle replacement.

Both are intended for cemented use only.

Six sizes are available for both devices.

The design concepts are equivalent.

The DePuy Tibial Tray uses a "keel" design approximately 10 mm in height. The Topez design is 10 mm.

The Talar Stem on the DePuy is also a "keel" design approximately 10 mm. Topez's design is 10 mm.

The DePuy tibial tray has integral sidewalls for Medial-Lateral constraint of the talus. Topez's design relies on the natural physiological constraint provided by the fibula, medial malleolus and concavity of the talar dome/UHMWPE interface. ( See: "Test 2: Determining the Constraint Characteristics of a Total Ankle Replacement"

Both devices have Accessory Cutting Jigs and Tool Kits used in the surgical process.

The DePuy prosthesis is designed to ±30 degrees rotation. Topez's rotation is +25 degrees, equal to the human anatomical range of motion for a walking gait.

Sterilization is accomplished by Gamma Radiation, different from DePuy but comparable.

Surgical training is required by both manufacturers as a prerequisite to implant the individual devices.

Porous coatings are used with both manufacturers' products. The plasma spray used by Topez accomplishes the same intended use as the porous coat used in the DePuy device. Use of the plasma spray by Topez does not bring up new issues of safety.

Contact area of the talus and UHMWPE is increased in the Topez prosthesis for reduced material stresses.

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Summary Page 8 of 8

NON-CLINICAL DATA

Risk Management following ISO 14971 demonstrates acceptable and mitigated potential hazards. Hazard Analysis is supported with Finite Element Analysis and Failure Modes Effects and Analysis.

1. Structural materials used meet ASTM standards:
- a. Cobalt-Chromium-Molybdenum, ASTM F1537
- b. Titanium, Ti-6A1-4V ELI, ASTM F136
- c. UHMWPE, GUR1020, ASTM F648
1. Performance Testing
- a. Test 1, Determining the Contact Surface Area and Stresses of a Total Ankle Replacement Articulating Surfaces - PASSES
- b. Test 2, Determining the Constraint Characteristics of a Total Ankle Replacement -PASSES
- c. Test 3, Determining the Disassembly Strength of the Tibial Tray and UHMPWE Insert of a Total Ankle Replacement With and Without Joint Reaction Force - PASSES
- d. Test 4, Test Protocol for Determining the Fatigue Strength of Tibial Stems of a Total Ankle Replacement - PASSES
- e. Test 5. Test Protocol for Disassembly Strength of a Calcaneal Stem PASSES
- f. Test 6. Determining the Assembly/Disassembly Strength of the Tibial Stem of a Total Ankle Replacement - PASSES
1. There are no new questions concerning safety and effectiveness.

Conclusion: The ankle prosthesis is designed, labeled, and verified for performance and safety. The device is substantially equivalent to legally marketed predicates.

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Image /page/8/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 5 2005

Topez Orthopedics, Inc. c/o Lewis Ward, Consultant L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, Colorado 80301

Re: K051023

Trade/Device Name: Topez Total Ankle Replacement Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HSN Dated: October 20, 2005 Received: October 24, 2005

Dear Mr. Ward:

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 comply 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 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.

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Page 2- Lewis Ward, Consultant

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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Acting 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

K05 1023 510(k) Number (if known):

Device Name: Topez Total Ankle Replacement

Indications for Use:

The ankle prosthesis is additionally indicated for patients with a failed previous ankle surgery.

CAUTION: The ankle prosthesis is intended for cemented use only.

Prescription Use X (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)

(Division Sign-Off) Division of Genera', Restorative, and Neurological Devices

510(k) Number K051023

Regulation Number and Section

§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.