(300 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical, describing a ceramic implant for joint replacement. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an implant used to treat conditions like arthritis, aiming to restore joint function and reduce pain, which are therapeutic goals.
No
The device description clearly states it "Acts as a spacer to preserve joint relationship and allow appropriate capsuloligamentous reconstruction to correct deformities." This describes a therapeutic, rather than a diagnostic, function.
No
The device description clearly states it is a "Ceramic Spherical Implant" and describes its physical properties and function as a spacer and articulating component, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Orthosphere® Ceramic Spherical Implant is a physical implant designed to be surgically placed within a joint (CMC or TMT) to act as a spacer and articulate directly on bone.
- Intended Use: The intended use describes the conditions the implant is used to treat (arthritis, decreased motion, pain, etc.) by physically replacing or supporting the joint structure. It does not involve testing samples from the body.
The information provided clearly describes a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
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
- 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.
Product codes (comma separated list FDA assigned to the subject device)
KYI,KWD
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 .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carpometacarpal (CMC) or 4"/5" tarsometatarsal (TMT) joint, midfoot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Logerot |
| Regulatory Affairs Specialist | |
| Proprietary Name: | Orthosphere® Spherical Implant |
| Common Name: | Ceramic Spherical Implant |
| Classification Name and Reference: | 21 CFR 888.3770 Prosthesis, Wrist, Carpal |
| trapezium - 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
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
1
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.
2
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.
3
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 .
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
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