510(k) · Cleared
ClearedAscension Pyrosphere (PCS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascension Orthopedics, Inc. · KYI Prosthesis, Wrist, Carpal Trapezium
Cleared on Nov 13, 2004 as substantially equivalent to K960659 (Wrightmedicaltechnologyinc, 1997) and 1 other predicate after a 45-day review. Its family tree reaches back 3 generations to 1987. 3 later devices descend from it.
- Decided
- Nov 13, 2004
- Review
- 45 days
- Class
- Class II
- Product code
- KYI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K864488 (1987). 4 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK864488 Swanson Titanium Condylar ImplantDow Corning Wright · 1987
- 2 generations backK964472 Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentBiologically Oriented Prostheses · 1997
- 1 generation backK041451 Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30…Ascension Orthopedics, Inc. · 2004 · Recalled
- This deviceK042690 Ascension Pyrosphere (PCS)Ascension Orthopedics, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK092548 Extremity Medical Trapezium ProsthesisExtremity Medical, LLC · 2009
- Descendant · cites it directly · 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 · cites it directly0descendants
- 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 |
|---|---|---|---|---|---|
| −3 | K864488 | Swanson Titanium Condylar Implant | Dow Corning Wright | 1987 | — |
| −2 | K964472 | Riopro Cobalt Trapeziometarcarpal Resurfacing Component | Biologically Oriented Prostheses | 1997 | — |
| −1 | K041451 | Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30… | Ascension Orthopedics, Inc. | 2004 | 2 |
| 0 (this device) | K042690 | Ascension Pyrosphere (PCS) | Ascension Orthopedics, Inc. | 2004 | — |
| +1 | K092548 | Extremity Medical Trapezium Prosthesis | Extremity Medical, LLC | 2009 | — |
| +1 | 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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
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 KYI? 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 KYI device
- #1 K201072 Ensemble CMC, Size 141, Ensemble CMC, Size…score 1.9 · 6 generations · no Class I recall
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 |
|---|---|---|---|
| * | K960659 | Ceramic Spherical CMC Implant (Subject to Marketing Approval)Summary page 1…DUCT CODE: 87 KYI PANEL: Orthopedic and Rehabilitation Devices PREDICATE DEVICE: Ceramic Zirconia Spherical CMC Implant (K960659) Ascension PyroHemiSphere (K041451) DEVICE DESCRIPTION: The Ascension PyroSphere (PCS) is a single-use, spherical, interposition… | 1997 |
| * | K041451 | Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40…Summary page 1…YI PANEL: Orthopedic and Rehabilitation Devices PREDICATE DEVICE: Ceramic Zirconia Spherical CMC Implant (K960659) Ascension PyroHemiSphere (K041451) DEVICE DESCRIPTION: The Ascension PyroSphere (PCS) is a single-use, spherical, interpositional prosthesis for the basal thumb j… | 2004 |
What descends from it? (3)
3 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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K092548 (Extremity Medical, LLC, 2009) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K960659.
How does its category compare?
All KYI devicesKYI Prosthesis, Wrist, Carpal Trapezium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KYI
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · KYI
Too few KYI 510(k)s in any year since 2007 to give a median.
Recalls per year · KYI
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KYI
1in 2024
MAUDE reports naming product code KYI, 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 | 2 | — | 0 | 32 |
| 2008 | 0 | — | 0 | 51 |
| 2009 | 1 | — | 0 | 56 |
| 2010 | 0 | — | 2 | 25 |
| 2011 | 2 | — | 0 | 72 |
| 2012 | 0 | — | 0 | 22 |
| 2013 | 0 | — | 0 | 23 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 3 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ascension® PyroSphere® is intended to replace the joint between the first metacarpal and the trapezium in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042690: Ascension Pyrosphere (PCS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042690
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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