510(k) Report

510(k) · Cleared

Cleared

Bridgepoint Spinous Process Camp- Posterior Fixation System

K103205510(k) TraditionalCleared Jun 2, 2011213-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

Alphatec Spine, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Jun 2, 2011 as substantially equivalent to K073278 (Nuvasive, Inc., 2008) after a 213-day review. Its family tree reaches back 1 generation to 2008. 14 later devices descend from it.

Decided
Jun 2, 2011
Review
213 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K073278 (2008). 14 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2015: 2 descendants cleared2013: 1 descendant cleared2018: 1 descendant cleared2021: 1 descendant cleared2022: 2 descendants cleared2020: 2 descendants cleared2017: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant clearedK073278 · Spinous Process Plate System · Nuvasive, Inc. · 200820052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 6 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K073278 · Spinous Process Plate System · Nuvasive, Inc. · 20080+5
  1. Root · 1 generation backK073278 Spinous Process Plate SystemNuvasive, Inc. · 2008
  2. This deviceK103205 Bridgepoint Spinous Process Camp- Posterior Fixation SystemAlphatec Spine, Inc. · 2011
  3. Descendant · cites it directly · 9 of its ownK140046 Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015
  4. Descendant · 2 generations on · 8 of its ownK151741 HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015
  5. Descendant · 3 generations on · 7 of its ownK163428 HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity · 2017
  6. Descendant · 2 generations on · 6 of its ownK200066 Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC · 2020
  7. Descendant · 2 generations on · 5 of its ownK212781 Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS…Spinal Simplicity, LLC · 2021

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12015: 22017: 12018: 12020: 22021: 12022: 22023: 12024: 12025: 1
2012high 2 (2015) · low 0 (2014)2026

Most influential descendants

Showing 5 of 14 · See all
  • K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015 · cites it directly9descendants
  • K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015 · 2 generations on8descendants
  • K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity · 2017 · 3 generations on7descendants
  • K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC · 2020 · 2 generations on6descendants
  • K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…Spinal Simplicity, LLC · 2021 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K073278Spinous Process Plate SystemNuvasive, Inc.2008—
0 (this device)K103205Bridgepoint Spinous Process Camp- Posterior Fixation SystemAlphatec Spine, Inc.2011—
+1K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC2015—
+2K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC2015—
+3K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity2017—
+2K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC2020—
+2K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion…Spinal Simplicity, LLC2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201520
201710
201810
202020
202110
202220
202310
202410
202510
FIG. 1 — Lineage of K103205, 2008–2025Source: 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 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? (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
*K073278Spinous Process Plate System
Summary page 1
…tial Equivalence: The RridgePoint T'" Spinous Process Clamp System is substantially equivalent in intended use and function to NuVasive® Spinous Process Plate System (k<073278) Confidential and Proprietary Page 23-2…
Nuvasive, Inc.2008—

Also cleared against K073278: 16 other devices →

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159
K121316Lanx Spinal Fization SystemLanx, Inc.20123

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, K140046 (Spinal Simplicity, LLC, 2015) has gone furthest, with 9 descendants of its own.
  • 16 other devices also cite its predicate K073278.

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. 2011, this device’s year, is highlighted.

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—

What is it indicated for?

The BridgePoint TM Spinous Process Clamp System is a posterior, non-pedicle supplemental fixation device, intended for use in non-cervical spine (Ti-Si). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondyl6[isthesis; trauma (i.e., fracture or dislocation); and/or tumor. It is not intended for stand alone use.

Indications for use as stated in the FDA summary.

Also cleared against K073278

16 other devices cite the same predicate.

  • K153302coflex-IFParadigm Spine, LLC · 2016
  • K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC · 2015
  • K142378Interspinous Plate SystemPrecision Spine, Inc. · 2014
  • K141508Romeo 2 Pad Posterior Axial DeviceSpineart · 2014
  • K133363Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc. · 2014
  • K133052Affix (R) Next Gen Spinous Process Plate SystemNuvasive, Inc. · 2013

More from Alphatec Spine, Inc.

96 FDA decisions under this applicant name. See the company

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc. · 2026
  • K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc. · 2026
  • K253615Invictus Bands SystemAlphatec Spine, Inc. · 2026
  • K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)Alphatec Spine, Inc. · 2026

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/K103205 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103205: Bridgepoint Spinous Process Camp- Posterior Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103205

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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