510(k) Report

510(k) · Cleared

Recalled · 2010

Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50

K041451510(k) TraditionalCleared Aug 25, 200485-day reviewClass II21 CFR 888.3770Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ascension Orthopedics, Inc. · KYI Prosthesis, Wrist, Carpal Trapezium

Cleared on Aug 25, 2004 as substantially equivalent to K864488 (Dow Corning Wright, 1987) and 2 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1987. 8 later devices descend from it. It has been recalled 2 times.

Decided
Aug 25, 2004
Review
85 days
Class
Class II
Product code
KYI
Recalls
2
Predicates
3

Its longest line of descent runs back 2 generations to K864488 (1987). 3 ancestors in all. 8 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor2004: 1 descendant cleared2006: 2 descendants cleared2011: 2 descendants cleared2020: 1 descendant cleared2009: 1 descendant cleared2008: 1 descendant clearedK864488 · Swanson Titanium Condylar Implant · Dow Corning Wright · 1987K964472 · Riopro Cobalt Trapeziometarcarpal Resurfacing Component · Biologically Oriented Prostheses · 19971990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 5 descendants K964472 · Riopro Cobalt Trapeziometarcarpal Resurfacing Component · Biologically Oriented Prostheses · 1997K864488 · Swanson Titanium Condylar Implant · Dow Corning Wright · 19870
  1. Root · 2 generations backK864488 Swanson Titanium Condylar ImplantDow Corning Wright · 1987
  2. 1 generation backK964472 Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentBiologically Oriented Prostheses · 1997
  3. This deviceK041451 Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30…Ascension Orthopedics, Inc. · 2004
  4. Descendant · cites it directly · 5 of its ownK061451 Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Ascension Orthopedics, Inc. · 2006 · Recalled
  5. Descendant · cites it directly · 3 of its ownK042690 Ascension Pyrosphere (PCS)Ascension Orthopedics, Inc. · 2004
  6. Descendant · 2 generations on · 2 of its ownK080997 Ascension Pyrocarbon LunateAscension Orthopedics, Inc. · 2008
  7. Descendant · 2 generations on · 1 of its ownK111068 Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC · 2011
  8. Descendant · 2 generations on · 1 of its ownK092548 Extremity Medical Trapezium ProsthesisExtremity Medical, LLC · 2009

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2004: 12006: 22008: 12009: 12011: 22020: 1
2004high 2 (2006) · low 0 (2005)2026

Most influential descendants

Showing 5 of 8 · See all
  • K061451Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Ascension Orthopedics, Inc. · 2006 · cites it directly5descendants
  • K042690Ascension Pyrosphere (PCS)Ascension Orthopedics, Inc. · 2004 · cites it directly3descendants
  • K080997Ascension Pyrocarbon LunateAscension Orthopedics, Inc. · 2008 · 2 generations on2descendants
  • K111068Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC · 2011 · 2 generations on1descendant
  • K092548Extremity Medical Trapezium ProsthesisExtremity Medical, LLC · 2009 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K864488Swanson Titanium Condylar ImplantDow Corning Wright1987—
−1K964472Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentBiologically Oriented Prostheses1997—
0 (this device)K041451Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30…Ascension Orthopedics, Inc.2004—
+1K061451Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Ascension Orthopedics, Inc.20061
+1K042690Ascension Pyrosphere (PCS)Ascension Orthopedics, Inc.2004—
+2K080997Ascension Pyrocarbon LunateAscension Orthopedics, Inc.2008—
+2K111068Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC2011—
+2K092548Extremity Medical Trapezium ProsthesisExtremity Medical, LLC2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200620
200810
200910
201120
202010
FIG. 1 — Lineage of K041451, 1987–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K201072 Ensemble CMC, Size 141, Ensemble CMC, Size…score 1.9 · 6 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K864488Swanson Titanium Condylar Implant
Summary page 1
…88.3770 PRODUCT CODE: 87 KY1 PAN EL: Orthopedic and Rehabilitation Devices PREDICATE DEVICE: Swanson 'Titanium Basal Thumb (K864488) Ceramic Zirconia Spherical CMC Implant (K960659) Biopro Cobalt Trapezionmetacarpal Replacement (K964472) DEVICE DESCRIPTION:…
Dow Corning Wright1987—
*K960659Ceramic Spherical CMC Implant (Subject to Marketing Approval)
Summary page 1
…PAN EL: Orthopedic and Rehabilitation Devices PREDICATE DEVICE: Swanson 'Titanium Basal Thumb (K864488) Ceramic Zirconia Spherical CMC Implant (K960659) Biopro Cobalt Trapezionmetacarpal Replacement (K964472) DEVICE DESCRIPTION: The Ascension PyroliemiSphere (PUS) is single-use…
Wrightmedicaltechnologyinc1997—
*K964472Riopro Cobalt Trapeziometarcarpal Resurfacing Component
Summary page 1
…ation Devices PREDICATE DEVICE: Swanson 'Titanium Basal Thumb (K864488) Ceramic Zirconia Spherical CMC Implant (K960659) Biopro Cobalt Trapezionmetacarpal Replacement (K964472) DEVICE DESCRIPTION: The Ascension PyroliemiSphere (PUS) is single-use, uncemecnted, one-component prosthesis for the basal t…
Biologically Oriented Prostheses1997—

Also cleared against K864488: 2 other devices →

What descends from it? (8)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061451Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Ascension Orthopedics, Inc.20065
K042690Ascension Pyrosphere (PCS)Ascension Orthopedics, Inc.20043
K112278Ascension Nugrip CMC ImplantAscension Orthopedic20110

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 12, 2010Not classifiedZ-0437-2011Mixed-up of materials/componentsTwo different product lots were found to be incorrectly labeled and placed into the incorrect box.
Jul 12, 2010Not classifiedZ-0438-2011Mixed-up of materials/componentsTwo different product lots were found to be incorrectly labeled and placed into the incorrect box.

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 9.8 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K061451 (Ascension Orthopedics, Inc., 2006) has gone furthest, with 5 descendants of its own.
  • 2 other devices also cite its predicate K864488.

How does its category compare?

All KYI devices

KYI Prosthesis, Wrist, Carpal Trapezium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KYI

1in 2020

2007: 22009: 12011: 22018: 12020: 1
2007high 2 (2007) · low 0 (2008)2026

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

2010: 22016: 1
2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KYI

1in 2024

2007: 322008: 512009: 562010: 252011: 722012: 222013: 232014: 42016: 32018: 42019: 142020: 82024: 1
2007high 72 (2011) · low 0 (2015)2025

MAUDE reports naming product code KYI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—032
20080—051
20091—056
20100—225
20112—072
20120—022
20130—023
20140—04
20150—00
20160—13
20170—00
20181—04
20190—014
20201—08
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—

What is it indicated for?

The Ascension® PyroHemiSphereTM is intended to replace the proximal end of the first metacarpal 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.

Also cleared against K864488

2 other devices cite the same predicate.

  • K052596Modular Thumb Implant, Models…Biopro, Inc. · 2005
  • K964472Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentBiologically Oriented Prostheses · 1997

More from Ascension Orthopedics, Inc.

22 FDA decisions under this applicant name. See the company

  • K233674Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc. · 2024
  • K233670Ascension Silicone MCP; Ascension Silicone PIPAscension Orthopedics, Inc. · 2023
  • K121826Integra Proximal Humeral Plate SystemAscension Orthopedics, Inc. · 2013
  • K110700Ascension Atlas Humeral Plating SystemAscension Orthopedics, Inc. · 2011
  • K102549The Ascension Movement Great Toe System Total ArthroplastyAscension Orthopedics, Inc. · 2010

Recent decisions in KYI

The KYI category page

  • K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC · 2020
  • K180744Stablyx CMC Arthroplasty Implant SystemSkeletal Dynamics, LLC · 2018
  • K111068Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC · 2011
  • K112278Ascension Nugrip CMC ImplantAscension Orthopedic · 2011
  • K092548Extremity Medical Trapezium ProsthesisExtremity Medical, LLC · 2009

https://510kreport.com/device/K041451 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041451: Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041451

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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