510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Scorpio Total Stablizer (TS) Total Knee System

K994128510(k) TraditionalCleared Mar 6, 200090-day reviewClass II21 CFR 888.3560Recalls 8

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

Howmedica Osteonics Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Mar 6, 2000 as substantially equivalent to K962152 (Osteonics Corp., 1996) and 5 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1992. 139 later devices descend from it. It has been recalled 8 times.

Decided
Mar 6, 2000
Review
90 days
Class
Class II
Product code
JWH
Recalls
8
Predicates
7

Its longest line of descent runs back 1 generation to K915192 (1992). 6 ancestors in all. 139 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1996: 2 other ancestors1993: 1 other ancestor1992: 1 other ancestor2016: 2 descendants cleared2025: 16 descendants cleared2002: 3 descendants cleared2012: 11 descendants cleared2024: 8 descendants cleared2003: 1 descendant cleared2004: 2 descendants cleared2007: 3 descendants cleared2009: 3 descendants cleared2014: 4 descendants cleared2017: 4 descendants cleared2018: 4 descendants cleared2019: 5 descendants cleared2026: 11 descendants cleared2021: 14 descendants cleared2022: 7 descendants cleared2020: 9 descendants cleared2006: 2 descendants cleared2015: 5 descendants cleared2008: 2 descendants cleared2010: 3 descendants cleared2011: 5 descendants cleared2013: 8 descendants cleared2023: 7 descendants clearedK915192 · 7000 Series Modular Tibial Components · Osteonics Corp. · 19921990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 6 descendants2 generations forward: 20 descendants3 generations forward: 14 descendants4 generations forward: 15 descendants5 generations forward: 28 descendants6 generations forward: 30 descendants7 generations forward: 16 descendants8 generations forward: 7 descendants9 generations forward: 3 descendants K915192 · 7000 Series Modular Tibial Components · Osteonics Corp. · 19920+5
  1. Root · 1 generation backK915192 7000 Series Modular Tibial ComponentsOsteonics Corp. · 1992
  2. This deviceK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000
  3. Descendant · cites it directly · 120 of its ownK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
  4. Descendant · 2 generations on · 96 of its ownK022672 Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · Recalled
  5. Descendant · 2 generations on · 80 of its ownK032108 Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc. · 2004
  6. Descendant · 2 generations on · 79 of its ownK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
  7. Descendant · 3 generations on · 78 of its ownK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled

Showing 5 of 139 descendants. See all descendants

Descendants cleared per year

2002: 32003: 12004: 22006: 22007: 32008: 22009: 32010: 32011: 52012: 112013: 82014: 42015: 52016: 22017: 42018: 42019: 52020: 92021: 142022: 72023: 72024: 82025: 162026: 11
2002high 16 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 139 · See all
  • K021313Search Evolution Total Knee SystemAesculap, Inc. · 2002 · cites it directly120descendants
  • K022672Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · 2 generations on96descendants
  • K032108Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc. · 2004 · 2 generations on80descendants
  • K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007 · 2 generations on79descendants
  • K081023Evolis Total Knee SystemMedacta International S.A. · 2008 · 3 generations on78descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K9151927000 Series Modular Tibial ComponentsOsteonics Corp.1992—
0 (this device)K994128Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp.2000—
+1K021313Search Evolution Total Knee SystemAesculap, Inc.2002—
+2K022672Columbus Total Knee System (CR)Aesculap, Inc.20021
+2K032108Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc.2004—
+2K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.2007—
+3K081023Evolis Total Knee SystemMedacta International S.A.20081

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199310
199620
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200310
200420
200620
200730
200820
200930
201030
201150
2012110
201380
201440
201550
201620
201740
201840
201950
202090
2021140
202270
202370
202480
2025160
2026110
FIG. 1 — Lineage of K994128, 1992–2026Source: 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 JWH? 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 JWH device

  1. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K962152Osteonics Scorpio Posteriorly Stabilized Total Knee System
Summary page 1
…bject devices are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA: K962152: Scorpio® Posteriorly Stabilized (PS) Total Knee System Femoral, Tibial Insert, and Patellar Components (sponsor: Osteonics) K97…
Osteonics Corp.199613
Kept off the family treeK974596FDA’s K974596 is Dimertest Latex Assay
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Agen Biomedical, Ltd.1998—
*K972967Osteonics Scorpio Total Knee Universal Dome Patellar Component;Osteonics Scorpio Total…
Summary page 1
…ert, and Patellar Components (sponsor: Osteonics) K9745¢6: Scorpio® Cruciate Retaining (CR) Total Knee System Femoral and Tibial Insert components (sponsor: Osteonics) K972967: Scorpio® Total Knee Universal Dome and Recessed Patellar Components (sponsor: Osteonics) K915192: 7000 Series Total Knee Modula…
Osteonics Corp.19986
*K9151927000 Series Modular Tibial Components
Summary page 1
…Knee System Femoral and Tibial Insert components (sponsor: Osteonics) K972967: Scorpio® Total Knee Universal Dome and Recessed Patellar Components (sponsor: Osteonics) K915192: 7000 Series Total Knee Modular Tibial Component (sponsor: Osteonics) K925372: 7000 Series Total Knee Modular Femoral Component (…
Osteonics Corp.1992—
*K925372Osteonics (R) 700 Series Total Knee Mod Femor Comp
Summary page 1
…: Scorpio® Total Knee Universal Dome and Recessed Patellar Components (sponsor: Osteonics) K915192: 7000 Series Total Knee Modular Tibial Component (sponsor: Osteonics) K925372: 7000 Series Total Knee Modular Femoral Component (sponsor: Osteonics) K920524: Osteonics Series 7000 Total Knee Tibial and Femor…
Osteonics Corp.1993—
*K920524Osteonics 7000 Series Total Knee Bone Augmentation
Summary page 1
…Osteonics) K915192: 7000 Series Total Knee Modular Tibial Component (sponsor: Osteonics) K925372: 7000 Series Total Knee Modular Femoral Component (sponsor: Osteonics) K920524: Osteonics Series 7000 Total Knee Tibial and Femoral Augmentation Blocks and Wedges (sponsor: Osteonics) K960279: Legacy Constra…
Osteonics Corp.1992—
*K960279Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral…
Summary page 1
…tal Knee Modular Femoral Component (sponsor: Osteonics) K920524: Osteonics Series 7000 Total Knee Tibial and Femoral Augmentation Blocks and Wedges (sponsor: Osteonics) K960279: Legacy Constrained Condylar Knee (CCK) (sponsor: Zimmer) Howmedica Osteonics Corp. Summary Page i Scorpio® Tota…
Zimmer, Inc.199621

Also cleared against K962152: 9 other devices →

What descends from it? (139)

See all 139

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

NumberDeviceApplicantDecidedDescendants
K021313Search Evolution Total Knee SystemAesculap, Inc.2002120
K030367Columbus (PS)Aesculap, Inc.200317
K160157LOSPA Modular Knee SystemCorentec Co., Ltd.20168
K113060Unity Toatal Knee SystemCorin USA20128
K243817Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20252
K234044ACS® LD FB Knee SystemImplantcast GmbH20241

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 1, 2023Class IIZ-0879-2024Nonconforming Material/ComponentProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Dec 1, 2023Class IIZ-0876-2024Nonconforming Material/ComponentProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Dec 1, 2023Class IIZ-0882-2024Nonconforming Material/ComponentProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Dec 1, 2023Class IIZ-0878-2024Nonconforming Material/ComponentProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Dec 1, 2023Class IIZ-0875-2024Nonconforming Material/ComponentProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Dec 1, 2023Class IIZ-0877-2024Nonconforming Material/ComponentProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Dec 1, 2023Class IIZ-0880-2024Nonconforming Material/ComponentProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
Dec 1, 2023Class IIZ-0881-2024Nonconforming Material/ComponentProduct manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 3 of the 6 ancestors have a recall of any class.
  • Of its descendants, K021313 (Aesculap, Inc., 2002) has gone furthest, with 120 descendants of its own.
  • 9 other devices also cite its predicate K962152.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JWH

20in 2025

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
2007high 109 (2009) · low 2 (2020)2026

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

Adverse event reports per year · JWH

9,306in 2025

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, 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
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

What is it indicated for?

The Scorpio® TS Total Knee System components are intended for single-use, and for cemented use only in the United States. The components feature a posterior cruciate ligament (PCL) substituting design. This system is intended for use when the cruciate ligaments are absent, inadequate, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to the absence of the posterior cruciate ligament and/or…

Read the full statement (256 words)

The Scorpio® TS Total Knee System components are intended for single-use, and for cemented use only in the United States. The components feature a posterior cruciate ligament (PCL) substituting design. This system is intended for use when the cruciate ligaments are absent, inadequate, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to the absence of the posterior cruciate ligament and/or patella. The collateral ligaments may or may not be intact. The system is also designed to allow compensation for bone loss through the use of blocks and wedges.

General TKR Indications

. Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.

. Post-traumatic loss of knee joint configuration and function.

. Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

. Revision of previous unsuccessful knee replacement or other procedure.

Additional Indications for Posterior Stabilized (PS) or Total Stabilized (TS) Components:

. Ligamentous instability requiring implant bearing surface geometries with increased constraint.

. Absent or non-functioning posterior cruciate ligament.

. Severe anteroposterior instability of the knee joint.

. For Total Stabilizer (TS) Components Only: Severe instability of the knee secondary to compromised collateral ligament integrity or function.

Indications for Bone Augmentation Wedges:

. Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.

. Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K962152

9 other devices cite the same predicate.

  • K152430All Poly Tibial ComponentUnited Orthopedic Corporation · 2016
  • K123166Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon All-Polyethylene Posterior…Howmedica Osteonics Corp. · 2013
  • K113060Unity Toatal Knee SystemCorin USA · 20123 recalls
  • K081127Accin Total Knee SystemAccelerated Innovation, LLC · 20081 recall
  • K033769Eius Unicompartmental Knee SystemHowmedica Osteonics Corp. · 2004
  • K030367Columbus (PS)Aesculap, Inc. · 20031 recall

More from Howmedica Osteonics Corp.

319 FDA decisions under this applicant name. See the company

  • P000013/S027Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® SystemHowmedica Osteonics Corp. · 2025
  • P000013/S026Trident Acetabular System: Trident Alumina InsertsHowmedica Osteonics Corp. · 2025
  • P000013/S025Trident® Acetabular SystemHowmedica Osteonics Corp. · 2024
  • P000013/S024Trident (R), ABC (R)Howmedica Osteonics Corp. · 2024
  • P000013/S021Trident Ceramic SystemHowmedica Osteonics Corp. · 2023

Recent decisions in JWH

The JWH category page

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https://510kreport.com/device/K994128 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994128: Scorpio Total Stablizer (TS) Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994128

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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