510(k) Report

510(k) · Cleared

Cleared

Cure™ Lumbar Plate System

K171538510(k) TraditionalCleared Jun 16, 201721-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

Meditech Spine, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jun 16, 2017 as substantially equivalent to K022791 (Synthes (Usa), 2002) after a 21-day review. Its family tree reaches back 1 generation to 2002. 19 later devices descend from it.

Decided
Jun 16, 2017
Review
21 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K022791 (2002). 19 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2024: 6 descendants cleared2019: 1 descendant cleared2018: 1 descendant cleared2020: 2 descendants cleared2026: 4 descendants cleared2022: 2 descendants cleared2025: 3 descendants clearedK022791 · Synthes Anterior Tension Band (Atb) System · Synthes (Usa) · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 4 descendants3 generations forward: 2 descendants4 generations forward: 3 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant K022791 · Synthes Anterior Tension Band (Atb) System · Synthes (Usa) · 20020+5
  1. Root · 1 generation backK022791 Synthes Anterior Tension Band (Atb) SystemSynthes (Usa) · 2002
  2. This deviceK171538 Cure™ Lumbar Plate SystemMeditech Spine, LLC · 2017
  3. Descendant · cites it directly · 12 of its ownK200885 Meridian Anterior Plate System, Regatta Lateral Plate SystemSeaSpine Orthopedics Corporation · 2020
  4. Descendant · 2 generations on · 10 of its ownK220711 SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation · 2022
  5. Descendant · 3 generations on · 9 of its ownK222732 WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2022
  6. Descendant · 3 generations on · 8 of its ownK233694 Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2024
  7. Descendant · 4 generations on · 3 of its ownK241466 Shoreline ACS Interbody System; Shoreline RT Interbody System…SeaSpine Orthopedics Corporation · 2024

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2018: 12019: 12020: 22022: 22024: 62025: 32026: 4
2018high 6 (2024) · low 0 (2021)2026

Most influential descendants

Showing 5 of 19 · See all
  • K200885Meridian Anterior Plate System, Regatta Lateral Plate SystemSeaSpine Orthopedics Corporation · 2020 · cites it directly12descendants
  • K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation · 2022 · 2 generations on10descendants
  • K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2022 · 3 generations on9descendants
  • K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation · 2024 · 3 generations on8descendants
  • K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation · 2024 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K022791Synthes Anterior Tension Band (Atb) SystemSynthes (Usa)2002—
0 (this device)K171538Cure™ Lumbar Plate SystemMeditech Spine, LLC2017—
+1K200885Meridian Anterior Plate System, Regatta Lateral Plate SystemSeaSpine Orthopedics Corporation2020—
+2K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation2022—
+3K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation2022—
+3K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation2024—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral…SeaSpine Orthopedics Corporation2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201910
202020
202220
202460
202530
202640
FIG. 1 — Lineage of K171538, 2002–2026Source: 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? (1)

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
*K022791Synthes Anterior Tension Band (Atb) System
Summary page 4
…Spinal intervertebral body fixation orthosis (21 CFR 888.3060 Class II,Product Code KWQ) C. Predicate Device: K022791 (Synthes Anterior Tension Band System) D. Device Description: The Cure™ Lumbar Plate System is composed of plates in a wide…
Synthes (Usa)2002—

Also cleared against K022791: 14 other devices →

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K200885Meridian Anterior Plate System, Regatta Lateral Plate SystemSeaSpine Orthopedics Corporation202012
K183214Raven Lumbar Plate SystemChoicespine, LP20192
K180090Cure™ Lumbar Plate SystemMeditech Spine, LLC20181
K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240
K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc.20240
K201136Cure™ Lumbar Plate SystemMeditech Spine, LLC20200

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?

  • Its one ancestor has no recall.
  • Of its descendants, K200885 (SeaSpine Orthopedics Corporation, 2020) has gone furthest, with 12 descendants of its own.
  • 14 other devices also cite its predicate K022791.

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. 2017, this device’s year, is highlighted.

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 Cure™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1‐L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1‐S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc…

Read the full statement (112 words)

The Cure™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1‐L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1‐S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

Indications for use as stated in the FDA summary.

Also cleared against K022791

14 other devices cite the same predicate.

  • K200846Balteum™ Lumbar Plate SystemHuvexel Co., Ltd. · 2020
  • K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine · 2018
  • K163625NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate SystemSignature Orthopaedics Pty, Ltd. · 2017
  • K124034Mectalif AnteriorMedacta International · 2013
  • K121791Zou Anterior Lumbar Plate SystemCorelink, LLC · 2012
  • K092765Lanx Anterior Plating SystemLanx, Inc. · 2010

More from Meditech Spine, LLC

10 FDA decisions under this applicant name. See the company

  • K210286Cure 2.0 Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC · 2021
  • K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion SystemMeditech Spine, LLC · 2020
  • K201136Cure™ Lumbar Plate SystemMeditech Spine, LLC · 2020
  • K181543Cure™ OPEL-C Plate SystemMeditech Spine, LLC · 2018
  • K180090Cure™ Lumbar Plate SystemMeditech Spine, LLC · 2018

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The KWQ category page

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https://510kreport.com/device/K171538 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171538: Cure™ Lumbar Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171538

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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