The Orthosphere® Ceramic Spherical Implant is indicated for use in cases of isolated carpometacarpal (CMC) or 4th/5th tarsometatarsal (TMT) joint involvement from either degenerative or post-traumatic arthritis presenting:

Decreased motion
X-ray evidence of arthritic changes and/or subluxation of the carpometacometacarpal or tarsometatarsal joints
Localized pain and palpable crepitation during circumduction movement with axial compression of the involved thumb ("grind test")
Associated unstable, stiff or painful distal joints
Decreased pinch and grip strength
Degenerative joint disease of the midfoot associated with gout or pseudogout

Only sizes 9mm-12mm are indicated for use in the 4th/5th tarsometatarsal joints. Sizes 9mm-14mm are indicated for use in the carpometacarpal (CMC) joints.

The Orthosphere® Ceramic Spherical Implant is for single use only.

Device Description

The design features of the Orthosphere® Ceramic Spherical Implant previously submitted and cleared are summarized below:

Manufactured from zirconia ceramic
Highly polished surface finish
Acts as a spacer to preserve joint relationship and allow appropriate capsuloligamentous reconstruction to correct deformities
Will rest in a spherical cavity and articulate directly on bone

AI/ML Overview

Here's an analysis of the provided text regarding the Orthosphere® Spherical Implant, focusing on acceptance criteria and the supporting study information:

Summary of Acceptance Criteria and Device Performance for the Orthosphere® Ceramic Spherical Implant

Based on the provided K030319 510(k) Summary, the device's acceptance criteria and demonstrated performance are primarily centered on substantial equivalence to predicate devices, rather than a direct performance study with quantitative metrics reported against specific acceptance criteria.

The key acceptance criteria appear to be alignment with the intended use, design features, material, and type of interface of already cleared predicate devices. The "performance" is implicitly deemed acceptable by meeting these equivalence standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit from text)	Reported Device Performance/Rationale
Intended Use	- Indicated for isolated carpometacarpal (CMC) or 4th/5th tarsometatarsal (TMT) joint involvement from degenerative or post-traumatic arthritis.	- Matches predicate: "The indications for use for the Orthosphere® Ceramic Spherical Implant are substantially equivalent to the indications for use previously submitted under Ceramic Spherical CMC." - Extended indication for TMT joints: "substantially equivalent to the indications for use of the Swanson Titanium Great Toe previously submitted and cleared." Both predicate and the Orthosphere articulate on bone, act as a spacer, and allow capsuloligamentous reconstruction.
Design Features	- Manufactured from zirconia ceramic.	- Identical to predicate: "The design features of the Orthosphere® Ceramic Spherical Implant are identical to the Ceramic Spherical CMC Implant." Also, "Manufactured from zirconia ceramic."
	- Highly polished surface finish.	- "Highly polished surface finish." (Implicitly identical to predicate)
	- Acts as a spacer to preserve joint relationship and allow appropriate capsuloligamentous reconstruction.	- "Acts as a spacer to preserve joint relationship and allow appropriate capsuloligamentous reconstruction to correct deformities." (Implicitly identical to predicate)
	- Rests in a spherical cavity and articulates directly on bone.	- "Will rest in a spherical cavity and articulate directly on bone." (Implicitly identical to predicate)
Material		- Substantially equivalent to predicates: "The material... of the Orthosphere® Ceramic Spherical Implant are substantially equivalent to the Ceramic Spherical CMC Implant and the Swanson Titanium Great Toe Implant."
Type of Interface		- Substantially equivalent to predicates: "The... type of interface of the Orthosphere® Ceramic Spherical Implant are substantially equivalent to the Ceramic Spherical CMC Implant and the Swanson Titanium Great Toe Implant."
Safety and Effectiveness	Adequately supported by substantial equivalence information and materials data (implicit acceptance criteria for a 510(k) submission).	- "Adequately supported by the substantial equivalence information and materials data provided within this Premarket Notification." The FDA's clearance letter confirms "the device is substantially equivalent... to legally marketed predicate devices."

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

No specific "test set" in the conventional sense (e.g., patient data, image dataset) is described for evaluating the Orthosphere® Ceramic Spherical Implant.
The study relies on substantial equivalence to existing predicate devices (Ceramic Spherical CMC Implant and Swanson Titanium Great Toe Implant).
Data provenance: Not applicable in the context of a comparative performance study. The "data" consists of design specifications, material properties, and intended uses compared against predicate devices, which would be based on data generated during the development and regulatory clearance of those predicate devices.

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

Not applicable. This submission doesn't describe a study where ground truth was established by human experts for a test set. The "ground truth" for the submission is the regulatory clearance and established safety/effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No test set or expert adjudication process 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

Not applicable. This is a medical device submission for an implant, not an AI/software device that would involve human readers or AI assistance.

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

Not applicable. This is a medical device submission for an implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission is the established safety and efficacy of the predicate devices, as determined through their prior FDA clearance processes. This would have involved a combination of materials testing, mechanical testing, clinical data (if required for the predicate), and ultimately, regulatory review and approval.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable. There is no training set mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word, there is a stylized graphic consisting of three curved lines that resemble wings or swooshes. The letters and graphic are all in black, contrasting with the white background. There is a small TM symbol in the bottom right corner of the image.

KO 30319
page 1 of 2

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the Orthosphere® Spherical Implant.

Submitted By:	Wright Medical Technology, Inc.
Date:	January 29, 2003
Contact Person:	Katie LogerotRegulatory Affairs Specialist
Proprietary Name:	Orthosphere® Spherical Implant
Common Name:	Ceramic Spherical Implant
Classification Name and Reference:	21 CFR 888.3770 Prosthesis, Wrist, Carpaltrapezium - Class II
	21 CFR 888.3730 Prosthesis, Toe, Hemi-,Phalangeal - Class II
Device Product Code and Panel Code:	Orthopedics/87/ KYI
	Orthopedics/87/KWD

DEVICE INFORMATION

A. INTENDED USE

The indications for use for the Orthosphere® Ceramic Spherical Implant are substantially equivalent to the indications for use previously submitted under Ceramic Spherical CMC.

The Orthosphere® Ceramic Spherical Implant is indicated for use in cases of isolated carpometacarpal (CMC) or 4"/5" tarsometatarsal (TMT) joint involvement from either degenerative or post-traumatic arthritis presenting:

Decreased motion
X-ray evidence of arthritic changes and/or subluxation of the carpometacarpal or . tarsometatarsal joints

headquarters

Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002

901.867.9971 phone

www.wmt.com

international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy

905.826.1600 Canada 011.81.3.3538.0474 Japan 011.33.1.45.13.24.40 France 011.44.1483.721.404 UK

011.49.4161.745130 Germany

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030319
page 2 of 2

Localized pain and palpable crepitation during circumduction movement with axial . compression of the involved thumb ("grind test")
Associated unstable, stiff, or painful distal joints ●
Decreased pinch and grip strength .
Degenerative joint disease of the midfoot associated with gout or pseudogout .

Only sizes 9mm-12mm are indicated for use in the tarsometatarsal (TMT) joints. Sizes 9mm-14mm are indicated for use in the carpometacarpal (CMC) joints.

The Orthosphere® Ceramic Spherical Implant is for single use only.

The extended indication for use of the Orthosphere® Ceramic Spherical Implant in the tarsometatarsal joint is substantially equivalent to the indications for use of the Swanson Titanium Great Toe previously submitted and cleared. Both implants articulate on bone and act as a spacer to preserve joint space and allow appropriate capsuloligamentous reconstruction in the foot.

B. DEVICE DESCRIPTION

The device description of the Orthosphere® Ceramic Spherical Implant is identical to the device description of the Ceramic Spherical CMC Implant.

The design features of the Orthosphere® Ceramic Spherical Implant previously submitted and cleared are summarized below:

Manufactured from zirconia ceramic .
Highly polished surface finish .
Acts as a spacer to preserve joint relationship and allow appropriate . capsuloligamentous reconstruction to correct deformities
Will rest in a spherical cavity and articulate directly on bone .

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features of the Orthosphere® Ceramic Spherical Implant are identical to the Ceramic Spherical CMC Implant. The material, intended use and type of interface of the Orthosphere® Ceramic Spherical Implant are substantially equivalent to the Ceramic Spherical CMC Implant and the Swanson Titanium Great Toe Implant. The safety and effectiveness of using this implant for interpositional arthroplasty of the foot are adequately supported by the substantial equivalence information and materials data provided within this Premarket Notification.

Image /page/1/Picture/18 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a serif font. Below "WRIGHT" are the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font. The logo is black and white.

Image /page/1/Picture/19 description: The image shows a black and white drawing of a planet. The planet has a rough surface with some dark spots. There is a ring around the planet, and the ring is thicker on one side than the other. The planet is in the lower left corner of the image.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

NOV 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Katie Logerot Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K030319

Trade/Device Name: ORTHOSPHERE® Ceramic Spherical Implant Regulation Numbers: 21 CFR 888.3730 Regulation Names: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II Product Codes: KWD Dated: August 28, 2003 Received: August 29, 2003

Dear Ms. Logerot:

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 10 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 - Ms. Katie Logerot

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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours,

Mark A. Milburn

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized graphic that resembles a bird in flight or a series of angled lines. The letters are large and prominent, and the graphic is smaller and positioned beneath the text. There is a TM symbol in the bottom right corner of the graphic.

ORTHOSPHERE® Ceramic Spherical Implant

INDICATIONS STATEMENT

The Orthosphere® Ceramic Spherical Implant is indicated for use in cases of isolated carpometacarpal (CMC) or 44/5th tarsometatarsal (TMT) joint involvement from either degenerative or post-traumatic arthritis presenting:

Decreased motion .
X-ray evidence of arthritic changes and/or subluxation of the carpometacarpal or . tarsometatarsal joints
Localized pain and palpable crepitation during circumduction movement with axial . compression of the involved thumb ("grind test")
Associated unstable, stiff or painful distal joints .

<030319

Decreased pinch and grip strength ●
Degenerative joint disease of the midfoot associated with gout or pseudogout ●

Only sizes 9mm-12mm are indicated for use in the 4th/5th tarsometatarsal joints. Sizes 9mm-14mm are indicated for use in the carpometacarpal (CMC) joints.

The Orthosphere® Ceramic Spherical Implant is for single use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per21 CFR 801.109)

for Mark AR. Miller

(Division Sign-Off) Division of General Restorative Devices 510(k) Number

Over-The Counter Use (Optional Format 1-2-96)

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K030319

headquarters Wright Medical Technology, Inc.

5677 Airline Road Arlington, TN 38002

901.867.9971 phone

www.wmt.com

international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy

905.826.1600 Canada 011.81.3.3538.0474 Japan 011-33-1.45.13.24.40 France 011.44.1483.721.404 UK

011.49.4161.745130 Germany

Regulation Number and Section

§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.

(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.