510(k) Report

510(k) · Cleared

Cleared

Synergy TI Anterior Spinal System

K950709510(k) TraditionalCleared Oct 25, 1995254-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

Cross Medical Products, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Oct 25, 1995 after a 254-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 541 later devices descend from it.

Decided
Oct 25, 1995
Review
254 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

541 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1998: 5 descendants cleared2009: 5 descendants cleared2010: 10 descendants cleared2011: 15 descendants cleared2014: 22 descendants cleared2012: 17 descendants cleared2008: 8 descendants cleared2007: 6 descendants cleared2018: 28 descendants cleared2017: 29 descendants cleared2025: 48 descendants cleared2006: 5 descendants cleared2013: 19 descendants cleared2019: 24 descendants cleared2000: 3 descendants cleared1999: 3 descendants cleared2021: 30 descendants cleared2016: 25 descendants cleared2024: 45 descendants cleared2022: 34 descendants cleared2023: 44 descendants cleared2015: 21 descendants cleared2020: 38 descendants cleared2026: 44 descendants cleared2002: 2 descendants cleared2005: 3 descendants cleared2003: 1 descendant cleared2004: 6 descendants cleared2001: 1 descendant cleared1995200020052010201520202025
  1. This deviceK950709 Synergy TI Anterior Spinal SystemCross Medical Products, Inc. · 1995
  2. Descendant · cites it directly · 529 of its ownK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
  3. Descendant · cites it directly · 311 of its ownK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
  4. Descendant · 2 generations on · 251 of its ownK982914 Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc. · 1998
  5. Descendant · 2 generations on · 251 of its ownK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
  6. Descendant · 3 generations on · 250 of its ownK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999

Showing 5 of 541 descendants. See all descendants

Descendants cleared per year

1998: 51999: 32000: 32001: 12002: 22003: 12004: 62005: 32006: 52007: 62008: 82009: 52010: 102011: 152012: 172013: 192014: 222015: 212016: 252017: 292018: 282019: 242020: 382021: 302022: 342023: 442024: 452025: 482026: 44
1998high 48 (2025) · low 1 (2001)2026

Most influential descendants

Showing 5 of 541 · See all
  • K973836Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy…Cross Medical Products, Inc. · 1998 · cites it directly529descendants
  • K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…Cross Medical Products, Inc. · 1998 · cites it directly311descendants
  • K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc. · 1998 · 2 generations on251descendants
  • K980484Aesculap Spine System EvolutionAesculap, Inc. · 1998 · 2 generations on251descendants
  • K990118Isobar Spinal SystemScien'Tx USA, Inc. · 1999 · 3 generations on250descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950709Synergy TI Anterior Spinal SystemCross Medical Products, Inc.1995—
+1K973836Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross…Cross Medical Products, Inc.1998—
+1K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy…Cross Medical Products, Inc.1998—
+2K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc.1998—
+2K980484Aesculap Spine System EvolutionAesculap, Inc.1998—
+3K990118Isobar Spinal SystemScien'Tx USA, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199850
199930
200030
200110
200220
200310
200460
200530
200650
200760
200880
200950
2010100
2011150
2012170
2013190
2014220
2015210
2016250
2017290
2018280
2019240
2020380
2021300
2022340
2023440
2024450
2025480
2026440
FIG. 1 — Lineage of K950709, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (541)

See all 541

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

NumberDeviceApplicantDecidedDescendants
K973836Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy…Cross Medical Products, Inc.1998529
K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…Cross Medical Products, Inc.1998311
K090523Polaris Spinal SystemEbi, L.P.2009156
K983353SCS Spinal SystemOrthotec, Inc.19982

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?

  • Of its descendants, K973836 (Cross Medical Products, Inc., 1998) has gone furthest, with 529 descendants of its own.

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—

More from Cross Medical Products, Inc.

7 FDA decisions under this applicant name. See the company

  • K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal…Cross Medical Products, Inc. · 1998
  • K973836Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy Anterior Spinal SystemCross Medical Products, Inc. · 1998
  • K940631Cross Medical - Synergy (TM) Spine SystemCross Medical Products, Inc. · 1995
  • K924381PWB Lumbar Laminar Hooks with Set ScrewsCross Medical Products, Inc. · 1993
  • K920116PWB Lumbosacral Spine SystemCross Medical Products, Inc. · 1992

Recent decisions in KWQ

The KWQ category page

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  • 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/K950709 · printed Nov 5, 2026

Cite this page

510(k) Report. “K950709: Synergy TI Anterior Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K950709

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026