510(k) · Cleared
Recalled · Class II · 2014Ascension Pyrosphere CMC/TMT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascension Orthopedics, Inc. · KWD Prosthesis, Toe, Hemi-, Phalangeal
Cleared on May 5, 2006 as substantially equivalent to K030319 (Wrightmedicaltechnologyinc, 2003) and 1 other predicate after a 64-day review. Its family tree reaches back 4 generations to 1987. It has been recalled once.
- Decided
- May 5, 2006
- Review
- 64 days
- Class
- Class II
- Product code
- KWD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K864488 (1987). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK864488 Swanson Titanium Condylar ImplantDow Corning Wright · 1987
- 3 generations backK964472 Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentBiologically Oriented Prostheses · 1997
- 2 generations backK041451 Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30…Ascension Orthopedics, Inc. · 2004 · Recalled
- 1 generation backK042690 Ascension Pyrosphere (PCS)Ascension Orthopedics, Inc. · 2004
- This deviceK060560 Ascension Pyrosphere CMC/TMTAscension Orthopedics, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864488 | Swanson Titanium Condylar Implant | Dow Corning Wright | 1987 | — |
| −3 | K964472 | Riopro Cobalt Trapeziometarcarpal Resurfacing Component | Biologically Oriented Prostheses | 1997 | — |
| −2 | K041451 | Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30… | Ascension Orthopedics, Inc. | 2004 | 2 |
| −1 | K042690 | Ascension Pyrosphere (PCS) | Ascension Orthopedics, Inc. | 2004 | — |
| 0 (this device) | K060560 | Ascension Pyrosphere CMC/TMT | Ascension Orthopedics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K030319 | Orthosphere Ceramic Spherical ImplantSummary page 1…21 CFR §888.3730 PRODUCT CODE: KWD PANEL: Orthopedic PREDICATE DEVICES: Orthosphere Ceramic Spherical Implant (K030319) Ascension® PyroSphere® (K042690) DEVICE DESCRIPTION: The Ascension Ascension® PyroSphereTM CMC/TMT is a single-use, spherical,… | 2003 |
| * | K042690 | Ascension Pyrosphere (PCS)Summary page 1…PRODUCT CODE: KWD PANEL: Orthopedic PREDICATE DEVICES: Orthosphere Ceramic Spherical Implant (K030319) Ascension® PyroSphere® (K042690) DEVICE DESCRIPTION: The Ascension Ascension® PyroSphereTM CMC/TMT is a single-use, spherical, interpositional prosthesis intend… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2014 | Class II | Z-0813-2015 | Nonconforming Material/Component | Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K030319.
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 Ascension® PyroSphereTM CMC/TMT 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.
The Ascension® PyroSphereTM CMC/TMT is also intended for use in the 4 t /5 th tarsometatarsal (TMT) joint involvement where degenerative or post-traumatic arthritis presents:
* decreased motion
* arthritic changes and/or subluxation
* unstable, stiff, or painful joints
* degenerative joint disease of the midfoot associated with gout or pseudogout
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060560: Ascension Pyrosphere CMC/TMT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060560
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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