510(k) · Cleared
ClearedOrthosphere Ceramic Spherical Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · KWD Prosthesis, Toe, Hemi-, Phalangeal
Cleared on Nov 26, 2003 after a 300-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Nov 26, 2003
- Review
- 300 days
- Class
- Class II
- Product code
- KWD
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK030319 Orthosphere Ceramic Spherical ImplantWrightmedicaltechnologyinc · 2003
- Descendant · cites it directly · 1 of its ownK092548 Extremity Medical Trapezium ProsthesisExtremity Medical, LLC · 2009
- Descendant · 2 generations on · 0 of its ownK201072 Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC · 2020
- Descendant · cites it directly · 0 of its ownK060560 Ascension Pyrosphere CMC/TMTAscension Orthopedics, Inc. · 2006 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K092548Extremity Medical Trapezium ProsthesisExtremity Medical, LLC · 2009 · cites it directly1descendant
- K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC · 2020 · 2 generations on0descendants
- K060560Ascension Pyrosphere CMC/TMTAscension Orthopedics, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030319 | Orthosphere Ceramic Spherical Implant | Wrightmedicaltechnologyinc | 2003 | — |
| +1 | K092548 | Extremity Medical Trapezium Prosthesis | Extremity Medical, LLC | 2009 | — |
| +2 | K201072 | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 | Ensemble Orthopedics, LLC | 2020 | — |
| +1 | K060560 | Ascension Pyrosphere CMC/TMT | Ascension Orthopedics, Inc. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWD device
- #1 K250074 HYALEX® MTP Hemiarthroplasty Implantscore 13.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Ceramic Spherical CMC Implant Named without a submission number | |
| * | — | Swanson Titanium Great Toe Implant Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092548 (Extremity Medical, LLC, 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KWD devicesKWD Prosthesis, Toe, Hemi-, Phalangeal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KWD
47in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWD
10in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWD
8in 2025
MAUDE reports naming product code KWD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 65 | 0 | 0 |
| 2008 | 3 | 84 | 1 | 2 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 3 | 47 | 0 | 1 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 0 | — | 1 | 3 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 1 | — | 1 | 7 |
| 2017 | 1 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 2 | — | 0 | 19 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 2 | — | 10 | 10 |
| 2023 | 1 | — | 0 | 27 |
| 2024 | 1 | — | 0 | 133 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
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 carpometacarpal or tarsometatarsal joints Localized pain and palpable crepitation during circumduction movement with axial compression of the involved thumb…
Read the full statement (116 words)
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 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030319: Orthosphere Ceramic Spherical Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030319
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026