510(k) Report

510(k) · Cleared

Cleared

Issys Pedicle Screw System

K043522510(k) TraditionalCleared Jan 14, 200525-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

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

Cleared on Jan 14, 2005 after a 25-day review. The FDA summary names its predicate without a number. 46 later devices descend from it.

Decided
Jan 14, 2005
Review
25 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

46 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2012: 4 descendants cleared2014: 2 descendants cleared2008: 2 descendants cleared2011: 3 descendants cleared2017: 2 descendants cleared2010: 2 descendants cleared2025: 2 descendants cleared2023: 3 descendants cleared2009: 1 descendant cleared2015: 4 descendants cleared2013: 2 descendants cleared2020: 3 descendants cleared2016: 4 descendants cleared2018: 4 descendants cleared2021: 1 descendant cleared2024: 2 descendants cleared2019: 1 descendant cleared2026: 1 descendant cleared2022: 1 descendant cleared20052010201520202025
  1. This deviceK043522 Issys Pedicle Screw SystemCustom Spine, Inc. · 2005
  2. Descendant · cites it directly · 42 of its ownK070245 Capsure Pedicle Screw SystemSpine Wave, Inc. · 2007
  3. Descendant · 2 generations on · 39 of its ownK081228 Capsure PS (R) Spine SystemSpine Wave, Inc. · 2008
  4. Descendant · 3 generations on · 36 of its ownK083353 Capsure (R) PS SystemSpine Wave, Inc. · 2008
  5. Descendant · 3 generations on · 33 of its ownK100605 Mis SystemSpine Wave, Inc. · 2010
  6. Descendant · 4 generations on · 16 of its ownK111115 Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc. · 2011

Showing 5 of 46 descendants. See all descendants

Descendants cleared per year

2007: 22008: 22009: 12010: 22011: 32012: 42013: 22014: 22015: 42016: 42017: 22018: 42019: 12020: 32021: 12022: 12023: 32024: 22025: 22026: 1
2007high 4 (2012) · low 1 (2009)2026

Most influential descendants

Showing 5 of 46 · See all
  • K070245Capsure Pedicle Screw SystemSpine Wave, Inc. · 2007 · cites it directly42descendants
  • K081228Capsure PS (R) Spine SystemSpine Wave, Inc. · 2008 · 2 generations on39descendants
  • K083353Capsure (R) PS SystemSpine Wave, Inc. · 2008 · 3 generations on36descendants
  • K100605Mis SystemSpine Wave, Inc. · 2010 · 3 generations on33descendants
  • K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc. · 2011 · 4 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K043522Issys Pedicle Screw SystemCustom Spine, Inc.2005—
+1K070245Capsure Pedicle Screw SystemSpine Wave, Inc.2007—
+2K081228Capsure PS (R) Spine SystemSpine Wave, Inc.2008—
+3K083353Capsure (R) PS SystemSpine Wave, Inc.2008—
+3K100605Mis SystemSpine Wave, Inc.2010—
+4K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200820
200910
201020
201130
201240
201320
201420
201540
201640
201720
201840
201910
202030
202110
202210
202330
202420
202520
202610
FIG. 1 — Lineage of K043522, 2005–2026Source: 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 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
Get a 510(k) Report

What was it cleared against? (4)

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
*—Moss- Miami Spinal System
Named without a submission number
—
*—Universal Spinal System
Named without a submission number
—
*—MIA Spinal System
Named without a submission number
—
*—Optima Spinal System
Named without a submission number
—

What descends from it? (46)

See all 46

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

NumberDeviceApplicantDecidedDescendants
K070245Capsure Pedicle Screw SystemSpine Wave, Inc.200742
K072866Issys LP Spinal Fixation SystemCustom Spine, Inc.20072
K113361Securis Spinal FixationCumtom Spine20120

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, K070245 (Spine Wave, Inc., 2007) has gone furthest, with 42 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—

What is it indicated for?

Custom Spine Issys Pedicle Screw System is used for the following human spine pathologies: * Deformity * Trauma & Tumor When used as pedicle screw fixation system of the non cervical posterior spine (TI-S I) in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed…

Read the full statement (132 words)

Custom Spine Issys Pedicle Screw System is used for the following human spine pathologies:

* Deformity

* Trauma & Tumor

When used as pedicle screw fixation system of the non cervical posterior spine (TI-S I) in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

In addition these systems are indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 and 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass

Indications for use as stated in the FDA summary.

More from Custom Spine, Inc.

12 FDA decisions under this applicant name. See the company

  • K143143Pathway ElifCustom Spine, Inc. · 2015
  • K132596Proposed OptimusCustom Spine, Inc. · 20141 recall
  • K120597KompredaCustom Spine, Inc. · 2013
  • K111726Pathway AvidCustom Spine, Inc. · 2012
  • K111099Issys LP Spinal Fixation SystemCustom Spine, Inc. · 20111 recall

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/K043522 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043522: Issys Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043522

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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