510(k) Report

510(k) · Cleared

Cleared

Cross Medical - Synergy (TM) Spine System

K940631510(k) TraditionalCleared Jul 13, 1995514-day reviewClass II21 CFR 888.3070

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. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Jul 13, 1995 after a 514-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 559 later devices descend from it.

Decided
Jul 13, 1995
Review
514 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
0

559 later devices descend from it, 16 citing it directly.

Descendants, by year cleared 2018: 31 descendants cleared1998: 5 descendants cleared2009: 5 descendants cleared2015: 22 descendants cleared2014: 21 descendants cleared2010: 9 descendants cleared2001: 2 descendants cleared2017: 31 descendants cleared2013: 19 descendants cleared2007: 7 descendants cleared2004: 7 descendants cleared2011: 14 descendants cleared2024: 48 descendants cleared2019: 26 descendants cleared2012: 18 descendants cleared2016: 27 descendants cleared2022: 34 descendants cleared2023: 47 descendants cleared2021: 31 descendants cleared2008: 8 descendants cleared2025: 48 descendants cleared2006: 5 descendants cleared2000: 3 descendants cleared1999: 3 descendants cleared2020: 38 descendants cleared2026: 44 descendants cleared2005: 3 descendants cleared2002: 2 descendants cleared2003: 1 descendant cleared1995200020052010201520202025
  1. This deviceK940631 Cross Medical - Synergy (TM) Spine 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 · cites it directly · 251 of its ownK982914 Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc. · 1998
  5. Descendant · cites it directly · 251 of its ownK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
  6. Descendant · 2 generations on · 250 of its ownK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999

Showing 5 of 559 descendants. See all descendants

Descendants cleared per year

1998: 51999: 32000: 32001: 22002: 22003: 12004: 72005: 32006: 52007: 72008: 82009: 52010: 92011: 142012: 182013: 192014: 212015: 222016: 272017: 312018: 312019: 262020: 382021: 312022: 342023: 472024: 482025: 482026: 44
1998high 48 (2024) · low 1 (2003)2026

Most influential descendants

Showing 5 of 559 · 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 · cites it directly251descendants
  • K980484Aesculap Spine System EvolutionAesculap, Inc. · 1998 · cites it directly251descendants
  • K990118Isobar Spinal SystemScien'Tx USA, Inc. · 1999 · 2 generations on250descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K940631Cross Medical - Synergy (TM) Spine 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—
+1K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc.1998—
+1K980484Aesculap Spine System EvolutionAesculap, Inc.1998—
+2K990118Isobar Spinal SystemScien'Tx USA, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199850
199930
200030
200120
200220
200310
200470
200530
200650
200770
200880
200950
201090
2011140
2012180
2013190
2014210
2015220
2016270
2017310
2018310
2019260
2020380
2021310
2022340
2023470
2024480
2025480
2026440
FIG. 1 — Lineage of K940631, 1995–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (559)

See all 559

16 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
K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc.1998251
K980484Aesculap Spine System EvolutionAesculap, Inc.1998251
K100438Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemEbi, L.P.2010104
K150417Astra Spine SystemSpinecraft, LLC201521
K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314
K012871Synergy TI Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176…Interpore Cross Intl.200111
K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410
K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188

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 MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

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
  • K950709Synergy TI Anterior Spinal 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 MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K940631 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940631: Cross Medical - Synergy (TM) Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940631

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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