510(k) Report

510(k) · Cleared

Cleared

Synthes (Usa)Titanium Locking Plate System (Tilps)

K970048510(k) TraditionalCleared Aug 1, 1997207-day reviewClass II21 CFR 888.3060

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

Synthes (Usa) · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Aug 1, 1997 as substantially equivalent to K926453 (Synthes (Usa), 1993) and 2 other predicates after a 207-day review. Its family tree reaches back 1 generation to 1993. 54 later devices descend from it.

Decided
Aug 1, 1997
Review
207 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K926453 (1993). 3 ancestors in all. 54 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1993: 1 other ancestor2008: 7 descendants cleared2001: 2 descendants cleared2004: 3 descendants cleared2017: 6 descendants cleared2000: 1 descendant cleared2012: 2 descendants cleared2007: 1 descendant cleared2015: 2 descendants cleared2021: 2 descendants cleared2009: 1 descendant cleared2005: 1 descendant cleared2013: 2 descendants cleared2026: 3 descendants cleared2006: 1 descendant cleared2019: 3 descendants cleared2018: 1 descendant cleared2023: 6 descendants cleared2020: 2 descendants cleared2022: 1 descendant cleared2025: 3 descendants cleared2024: 4 descendants clearedK926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 7 descendants2 generations forward: 9 descendants3 generations forward: 12 descendants4 generations forward: 10 descendants5 generations forward: 4 descendants6 generations forward: 8 descendants7 generations forward: 3 descendants8 generations forward: 1 descendant K926453 · Synthes (U.S.a.) Anterior Cervical Vertebrae Plate · Synthes (Usa) · 19930+5
  1. Root · 1 generation backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
  2. This deviceK970048 Synthes (Usa)Titanium Locking Plate System (Tilps)Synthes (Usa) · 1997
  3. Descendant · cites it directly · 43 of its ownK010466 Tether AcfsTheken Surgical,Llc · 2001
  4. Descendant · 2 generations on · 21 of its ownK121514 Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012
  5. Descendant · 3 generations on · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
  6. Descendant · 4 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
  7. Descendant · 2 generations on · 12 of its ownK040003 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004

Showing 5 of 54 descendants. See all descendants

Descendants cleared per year

2000: 12001: 22004: 32005: 12006: 12007: 12008: 72009: 12012: 22013: 22015: 22017: 62018: 12019: 32020: 22021: 22022: 12023: 62024: 42025: 32026: 3
2000high 7 (2008) · low 0 (2002)2026

Most influential descendants

Showing 5 of 54 · See all
  • K010466Tether AcfsTheken Surgical,Llc · 2001 · cites it directly43descendants
  • K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012 · 2 generations on21descendants
  • K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017 · 3 generations on18descendants
  • K190016Lateral Plate SystemCorelink, LLC · 2019 · 4 generations on15descendants
  • K040003Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004 · 2 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K926453Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa)1993—
0 (this device)K970048Synthes (Usa)Titanium Locking Plate System (Tilps)Synthes (Usa)1997—
+1K010466Tether AcfsTheken Surgical,Llc2001—
+2K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC2012—
+3K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC2017—
+4K190016Lateral Plate SystemCorelink, LLC2019—
+2K040003Vertebron SCP Cervical Plate SystemVertebron, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200120
200430
200510
200610
200710
200870
200910
201220
201320
201520
201760
201810
201930
202020
202120
202210
202360
202440
202530
202630
FIG. 1 — Lineage of K970048, 1993–2026Source: 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 KWQ? 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 KWQ device

  1. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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
*K926453Synthes (U.S.a.) Anterior Cervical Vertebrae Plate
Summary page 1
…Russell Road Contact: Paoli, PA 19301 Barry E. Sands Synthes Titanium Locking Plate System (TiLPS) is compared to the Synthes Anterior Cervical Vertebrae Plate System (K926453 and K945700), and the Synthes Anterior Spinal Plate System (K925351). The Synthes TiLPS is intended for anterior intravertebral…
Synthes (Usa)1993—
*K945700Synthes (Usa) Anterior Cervical Vertebrae Plate System
Summary page 1
…d Contact: Paoli, PA 19301 Barry E. Sands Synthes Titanium Locking Plate System (TiLPS) is compared to the Synthes Anterior Cervical Vertebrae Plate System (K926453 and K945700), and the Synthes Anterior Spinal Plate System (K925351). The Synthes TiLPS is intended for anterior intravertebral body screw f…
Synthes (Usa)1995—
*K925351Synthes (U.S.a.) Anterior Spinal Plate
Summary page 1
…ium Locking Plate System (TiLPS) is compared to the Synthes Anterior Cervical Vertebrae Plate System (K926453 and K945700), and the Synthes Anterior Spinal Plate System (K925351). The Synthes TiLPS is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral…
Synthes (Usa)1993—

Also cleared against K926453: 14 other devices →

What descends from it? (54)

See all 54

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

NumberDeviceApplicantDecidedDescendants
K010466Tether AcfsTheken Surgical,Llc200143
K040130Anterior Lumbar Buttress SystemSeaspine20044
K012881C3 Anterior Cervical Plate SystemSpine Vision, Inc.20014
K073349Reliance Buttress Washer SystemReliance Medical Systems, LLC20081
K170530Butrex Lumbar Buttress Plating SystemX-Spine Systems, Inc.20170
K081418Spinal Elements Buttress Plate SystemSpinal Elements, Inc.20080
K994383Dogbone AcfsTheken Surgical20000

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K010466 (Theken Surgical,Llc, 2001) has gone furthest, with 43 descendants of its own.
  • 14 other devices also cite its predicate K926453.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

What is it indicated for?

The Synthes TiLPS is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervetebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease.

DDD is defined as follows: back pain of a discogenic origin with degeneration of the disc confirmed by history and radiographic studies

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 K926453

14 other devices cite the same predicate.

  • K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc. · 2019
  • K1824894CIS® Pinehurst Anterior Cervical Plate systemSolco Biomedical Co., Ltd. · 2019
  • K160604Cure™ Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC · 2016
  • K153042TRYPTIK2C-plate Anterior Cervical Plate SystemSpineart · 20167 recalls
  • K113170Cervical PlateEisertech, LLC · 2012
  • K101848Sapphire Anterior Cervical Plate SystemSpinal Elements, Inc. · 2010

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

Recent decisions in KWQ

The KWQ category page

  • K262149corra® cervical plating systemCarlsmed, Inc. · 2026
  • K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC · 2026
  • K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
  • K260570corra™ cervical plating systemCarlsmed, Inc. · 2026

https://510kreport.com/device/K970048 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970048: Synthes (Usa)Titanium Locking Plate System (Tilps).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970048

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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