510(k) Report

510(k) · Cleared

Cleared

Modification to Synergy Spinal System

K010515510(k) SpecialCleared Mar 22, 200128-day reviewClass II21 CFR 888.3050

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

Interpore Cross Intl. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Mar 22, 2001 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.

Decided
Mar 22, 2001
Review
28 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

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

Descendants, by year cleared 2007: 2 descendants cleared2023: 1 descendant cleared2002: 1 descendant cleared2004: 1 descendant cleared2008: 1 descendant cleared2013: 1 descendant cleared2009: 1 descendant cleared2011: 2 descendants cleared2024: 4 descendants cleared2012: 2 descendants cleared2025: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK010515 Modification to Synergy Spinal SystemInterpore Cross Intl. · 2001
  2. Descendant · cites it directly · 5 of its ownK072426 Atlas Spine Pedicle Screw SystemAtlas Spine, LLC · 2007 · Recalled
  3. Descendant · cites it directly · 4 of its ownK232341 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2023
  4. Descendant · 2 generations on · 4 of its ownK110842 Atlas Spine Pedicle Screw SystemAtlas Spine, Inc. · 2011
  5. Descendant · 2 generations on · 3 of its ownK233944 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2024
  6. Descendant · cites it directly · 3 of its ownK020085 Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.XSintea Biotech, Inc. · 2002

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2002: 12004: 12007: 22008: 12009: 12011: 22012: 22013: 12023: 12024: 42025: 12026: 1
2002high 4 (2024) · low 0 (2003)2026

Most influential descendants

Showing 5 of 18 · See all
  • K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC · 2007 · cites it directly5descendants
  • K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2023 · cites it directly4descendants
  • K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc. · 2011 · 2 generations on4descendants
  • K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2024 · 2 generations on3descendants
  • K020085Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.XSintea Biotech, Inc. · 2002 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010515Modification to Synergy Spinal SystemInterpore Cross Intl.2001—
+1K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC20071
+1K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.2023—
+2K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.2011—
+2K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.2024—
+1K020085Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.XSintea Biotech, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
200720
200810
200910
201120
201220
201310
202310
202440
202510
202610
FIG. 1 — Lineage of K010515, 2001–2026Source: 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 KWP? 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? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC20075
K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234
K020085Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.XSintea Biotech, Inc.20023
K070966Gso GS1 Spinal SystemGold Standard Orthopaedics, LLC20072

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, K072426 (Atlas Spine, LLC, 2007) has gone furthest, with 5 descendants of its own.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

More from Interpore Cross Intl.

39 FDA decisions under this applicant name. See the company

  • K050861Peek CasInterpore Cross Intl. · 2005
  • K031399Intergro DBMInterpore Cross Intl. · 20051 recall
  • K041407Titanium Mesh ImplantInterpore Cross Intl. · 2004
  • K043229Modification to Altius Oct SystemInterpore Cross Intl. · 2004
  • K042798C-Tek C-Trun Anterior Cervical Plate SystemInterpore Cross Intl. · 2004

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K010515 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010515: Modification to Synergy Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010515

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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