510(k) Report

510(k) · Cleared

Cleared

Able Medical Devices Valkyrie Thoracic Fixation System

K202889510(k) TraditionalCleared Mar 2, 2021155-day reviewClass II21 CFR 888.3030

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

Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · HRS Plate, Fixation, Bone

Cleared on Mar 2, 2021 as substantially equivalent to K163007 (Biomet Microfixation, 2016) and 7 other predicates after a 155-day review. Its family tree reaches back 14 generations to 1976. 39 later devices descend from it.

Decided
Mar 2, 2021
Review
155 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
8

Its longest line of descent runs back 14 generations to K761228 (1976). 100 ancestors in all. 39 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2017: 1 other ancestor2016: 2 other ancestors2015: 1 other ancestor2012: 1 other ancestor2011: 2 other ancestors2007: 1 other ancestor2003: 6 other ancestors2001: 4 other ancestors1995: 5 other ancestors1994: 9 other ancestors2010: 1 other ancestor2006: 3 other ancestors2004: 2 other ancestors2005: 1 other ancestor2002: 2 other ancestors2000: 3 other ancestors1999: 5 other ancestors1998: 11 other ancestors1997: 5 other ancestors1993: 4 other ancestors1996: 10 other ancestors1990: 2 other ancestors1992: 1 other ancestor1991: 1 other ancestor1988: 1 other ancestor1986: 2 other ancestors2021: 1 descendant cleared2023: 6 descendants cleared2022: 3 descendants cleared2024: 10 descendants cleared2025: 11 descendants cleared2026: 8 descendants clearedK761228 · Luhr Mandibular Compression-Screw System · Howmedica Corp. · 1976K963739 · Leibinger - Luhr Small Orthopedic Bone Screws · Howmedica Leibinger, Inc. · 1997×2: 2 generations cleared close together, K970912 (1997), K974785 (1998) K013954 · Lorenz Self Drilling Screws · Walter Lorenz Surgical, Inc. · 2002×2: 2 generations cleared close together, K032228 (2003), K033740 (2003) K063506 · Lorenz Sternal Closure System · Walter Lorenz Surgical, Inc. · 2006K110574 · Biomet Microfixation Sternalock Blu Sternal Closure System · Biomet Microfixation, Inc. · 2011 · recalledK122293 · Pioneer Sternal Cable Plate System · Pioneer Surgical Technology, Inc. · 2012K133785 · Tritium Sternal Cable Plate System · Pioneer Surgical Technology, Inc. · 2014 · recalledK150581 · Tritium Sternal Cable Plate System · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015K161876 · Tritium® Sternal Cable Plate System · Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2016K193468 · Tritium Sternal Cable Plate System · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 202019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 7 other ancestors3 generations back: 7 other ancestors4 generations back: 16 other ancestors5 generations back: 23 other ancestors6 generations back: 10 other ancestors7 generations back: 15 other ancestors8 generations back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 5 descendants3 generations forward: 13 descendants4 generations forward: 16 descendants5 generations forward: 2 descendants K193468 · Tritium Sternal Cable Plate System · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2020K161876 · Tritium® Sternal Cable Plate System · Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2016K150581 · Tritium Sternal Cable Plate System · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015K133785 · Tritium Sternal Cable Plate System · Pioneer Surgical Technology, Inc. · 2014 · recalledK122293 · Pioneer Sternal Cable Plate System · Pioneer Surgical Technology, Inc. · 2012K110574 · Biomet Microfixation Sternalock Blu Sternal Closure System · Biomet Microfixation, Inc. · 2011 · recalledK063506 · Lorenz Sternal Closure System · Walter Lorenz Surgical, Inc. · 2006K033740 · Lorenz Sternal Closure System · Walter Lorenz Surgical, Inc. · 2003K032228 · Lorenz 2.4 Self Drilling Screws · Walter Lorenz Surgical, Inc. · 2003K013954 · Lorenz Self Drilling Screws · Walter Lorenz Surgical, Inc. · 2002K974785 · Auto-Drive Bone Screw · Osteomed Corp. · 1998K970912 · Leibinger Self-Drilling Screw · Howmedica Leibinger, Inc. · 1997K963739 · Leibinger - Luhr Small Orthopedic Bone Screws · Howmedica Leibinger, Inc. · 1997K761228 · Luhr Mandibular Compression-Screw System · Howmedica Corp. · 1976−10−50+5
  1. Root · 14 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
  2. 10 generations between
  3. 3 generations backK150581 Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015
  4. 2 generations backK161876 Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2016
  5. 1 generation backK193468 Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2020
  6. This deviceK202889 Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021
  7. Descendant · cites it directly · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
  8. Descendant · 2 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
  9. Descendant · 2 generations on · 13 of its ownK222973 IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous…Alphatec Spine, Inc. · 2022
  10. Descendant · 2 generations on · 8 of its ownK232432 E3D™-A Interbody SystemEvolution Spine · 2024
  11. Descendant · 3 generations on · 7 of its ownK240368 E3D™-A Interbody SystemEvolution Spine · 2024
Show all 14 generations
  1. Root · 14 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
  2. 13 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
  3. 12 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
  4. 11 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
  5. 10 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
  6. 9 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
  7. 8 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
  8. 7 generations backK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
  9. 6 generations backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
  10. 5 generations backK122293 Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2012
  11. 4 generations backK133785 Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2014 · Recalled
  12. 3 generations backK150581 Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015
  13. 2 generations backK161876 Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2016
  14. 1 generation backK193468 Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2020
  15. This deviceK202889 Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2021: 12022: 32023: 62024: 102025: 112026: 8
2021high 11 (2025) · low 1 (2021)2026

Most influential descendants

Showing 5 of 39 · See all
  • K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · cites it directly36descendants
  • K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 2 generations on28descendants
  • K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc. · 2022 · 2 generations on13descendants
  • K232432E3D™-A Interbody SystemEvolution Spine · 2024 · 2 generations on8descendants
  • K240368E3D™-A Interbody SystemEvolution Spine · 2024 · 3 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K761228Luhr Mandibular Compression-Screw SystemHowmedica Corp.1976—
−13K963739Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc.1997—
−12K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc.1997—
−11K974785Auto-Drive Bone ScrewOsteomed Corp.1998—
−10K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc.2002—
−9K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc.2003—
−8K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2003—
−7K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2006—
−6K110574Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc.20111
−5K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc.2012—
−4K133785Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc.20141
−3K150581Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2015—
−2K161876Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.2016—
−1K193468Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2020—
0 (this device)K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices2021—
+1K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System…Alphatec Spine, Inc.2022—
+2K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System…Alphatec Spine2022—
+2K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti…Alphatec Spine, Inc.2022—
+2K232432E3D™-A Interbody SystemEvolution Spine2024—
+3K240368E3D™-A Interbody SystemEvolution Spine2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198620
198810
199020
199110
199210
199340
199490
199550
1996100
199750
1998110
199950
200030
200140
200220
200360
200420
200510
200630
200710
201010
201120
201210
201510
201620
201710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202230
202360
2024100
2025110
202680
FIG. 1 — Lineage of K202889, 1976–2026Source: 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 HRS? 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 HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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? (8)

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
*K163007Biomet Microfixation SternaLock 360 Sternal Closure System
Summary page 5
…Trade or Proprietary or Manufacturer Predicate Model Name Type K163007, K151019, Biomet Microfixation Biomet Microfixation Primary K121302, K110574 Sternalock 360…
Biomet Microfixation2016—
*K151019SternaLock® 360 Sternal Closure System
Summary page 5
…Trade or Proprietary or Manufacturer Predicate Model Name Type K163007, K151019, Biomet Microfixation Biomet Microfixation Primary K121302, K110574 Sternalock 360 Sternal…
Biomet Microfixation2015—
*K121302Biomet Microfixation Sternal Closure System
Summary page 5
…Model Name Type K163007, K151019, Biomet Microfixation Biomet Microfixation Primary K121302, K110574 Sternalock 360 Sternal Closure System K193468, K133785 Tritium St…
Biomet Microfixation2012—
*K110574Biomet Microfixation Sternalock Blu Sternal Closure System
Summary page 5
…Model Name Type K163007, K151019, Biomet Microfixation Biomet Microfixation Primary K121302, K110574 Sternalock 360 Sternal Closure System K193468, K133785 Tritium Sternal Cab…
Biomet Microfixation, Inc.20111
*K193468Tritium Sternal Cable Plate System
Summary page 5
…Biomet Microfixation Biomet Microfixation Primary K121302, K110574 Sternalock 360 Sternal Closure System K193468, K133785 Tritium Sternal Cable Plate Pioneer Surgical Additional System…
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2020—
*K133785Tritium Sternal Cable Plate System
Summary page 5
…iomet Microfixation Biomet Microfixation Primary K121302, K110574 Sternalock 360 Sternal Closure System K193468, K133785 Tritium Sternal Cable Plate Pioneer Surgical Additional System…
Pioneer Surgical Technology, Inc.20141
*K151983KLS Martin LSS Plating System
Summary page 5
…3468, K133785 Tritium Sternal Cable Plate Pioneer Surgical Additional System Technology, Inc. K151983 KLS Martin LSS Plating KLS Martin L.P. Additional System K170…
KLS Martin L.P.2016—
*K170767Surgical Stainless Steel Suture, Stainless Steel Suture
Summary page 5
…Technology, Inc. K151983 KLS Martin LSS Plating KLS Martin L.P. Additional System K170767 Stainless Steel Suture Ethicon Incorporated Additional PERFORMANCE DATA The Valkyrie Thoracic Fi…
ETHICON, Inc.2017—

What descends from it? (39)

See all 39

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

NumberDeviceApplicantDecidedDescendants
K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236
K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211
K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230

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 45 years and passes through 9 companies; a new generation was cleared every 1.4 years on median.
  • 8 of the 100 ancestors have a recall of any class.
  • Of its descendants, K220782 (Alphatec Spine, Inc., 2022) has gone furthest, with 36 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The Valkyrie Thoracic Fixation System is intended for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality.

Indications for use as stated in the FDA summary.

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K202889 · printed Nov 4, 2026

Cite this page

510(k) Report. “K202889: Able Medical Devices Valkyrie Thoracic Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K202889

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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