510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Issys LP Spinal Fixation System

K072866510(k) TraditionalCleared Dec 13, 200769-day reviewClass II21 CFR 888.3050Recalls 1

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 Dec 13, 2007 as substantially equivalent to K070281 (Custom Spine, Inc., 2007) and 7 other predicates after a 69-day review. Its family tree reaches back 4 generations to 1996. 2 later devices descend from it. It has been recalled once.

Decided
Dec 13, 2007
Review
69 days
Class
Class II
Product code
KWP
Recalls
1
Predicates
8

Its longest line of descent runs back 4 generations to K955348 (1996). 14 ancestors in all, the oldest K933881 (1994). 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2005: 1 other ancestor2003: 1 other ancestor1998: 1 other ancestor1994: 1 other ancestor2002: 1 other ancestor2000: 4 other ancestors2011: 1 descendant cleared2012: 1 descendant clearedK955348 · Titanium Moss Miami Spinal System · Depuy, Inc. · 1996K964024 · Depuy Motech Titanium Moss Miami Spinal System · Depuy, Inc. · 1997K992168 · Moss Miami 6.35MM Polyaxial Screw · Depuyacromed · 1999K022623 · 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) · Depuyacromed · 20021990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 4 other ancestors3 generations back: 1 other ancestor 1 generation forward: 2 descendants K022623 · 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) · Depuyacromed · 2002K992168 · Moss Miami 6.35MM Polyaxial Screw · Depuyacromed · 1999K964024 · Depuy Motech Titanium Moss Miami Spinal System · Depuy, Inc. · 1997K955348 · Titanium Moss Miami Spinal System · Depuy, Inc. · 19960
  1. Root · 4 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
  2. 3 generations backK964024 Depuy Motech Titanium Moss Miami Spinal SystemDepuy, Inc. · 1997
  3. 2 generations backK992168 Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 1999
  4. 1 generation backK022623 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed · 2002
  5. This deviceK072866 Issys LP Spinal Fixation SystemCustom Spine, Inc. · 2007
  6. Descendant · cites it directly · 1 of its ownK111099 Issys LP Spinal Fixation SystemCustom Spine, Inc. · 2011 · Recalled
  7. Descendant · cites it directly · 0 of its ownK113361 Securis Spinal FixationCumtom Spine · 2012

Most influential descendants

Showing 2 of 2 · See all
  • K111099Issys LP Spinal Fixation SystemCustom Spine, Inc. · 2011 · cites it directly1descendant
  • K113361Securis Spinal FixationCumtom Spine · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K955348Titanium Moss Miami Spinal SystemDepuy, Inc.1996—
−3K964024Depuy Motech Titanium Moss Miami Spinal SystemDepuy, Inc.1997—
−2K992168Moss Miami 6.35MM Polyaxial ScrewDepuyacromed1999—
−1K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed2002—
0 (this device)K072866Issys LP Spinal Fixation SystemCustom Spine, Inc.2007—
+1K111099Issys LP Spinal Fixation SystemCustom Spine, Inc.20111
+1K113361Securis Spinal FixationCumtom Spine2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199810
200040
200210
200310
200510
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
FIG. 1 — Lineage of K072866, 1996–2012Source: 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? (8)

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
*K070281Issys LP Spinal Fixation System
Summary page 1
…anel: Orthopedics Product Code: NKB,KWP,MNJ,MNH Proprietary Name: ISSYS LP Spinal Fixation System Predicate Devices: ISSYSTm LP Spinal Fixation System (K070281) ISSYSTM Pedicle Screw System (K043522) Moss®k Miami Spinal System (K933881, K955348,…
Custom Spine, Inc.20071
*K043522Issys Pedicle Screw System
Summary page 1
…prietary Name: ISSYS LP Spinal Fixation System Predicate Devices: ISSYSTm LP Spinal Fixation System (K070281) ISSYSTM Pedicle Screw System (K043522) Moss®k Miami Spinal System (K933881, K955348, K964024, K983583, K022623)…
Custom Spine, Inc.2005—
*K933881Depuy Motech Moss-Miami Spinal System
Summary page 1
…te Devices: ISSYSTm LP Spinal Fixation System (K070281) ISSYSTM Pedicle Screw System (K043522) Moss®k Miami Spinal System (K933881, K955348, K964024, K983583, K022623) Optima® Spinal System (K031t585) Device Descrip…
Depuy, Inc.1994—
*K955348Titanium Moss Miami Spinal System
Summary page 1
…s: ISSYSTm LP Spinal Fixation System (K070281) ISSYSTM Pedicle Screw System (K043522) Moss®k Miami Spinal System (K933881, K955348, K964024, K983583, K022623) Optima® Spinal System (K031t585) Device Description: T…
Depuy, Inc.1996—
*K964024Depuy Motech Titanium Moss Miami Spinal System
Summary page 1
…YSTm LP Spinal Fixation System (K070281) ISSYSTM Pedicle Screw System (K043522) Moss®k Miami Spinal System (K933881, K955348, K964024, K983583, K022623) Optima® Spinal System (K031t585) Device Description: The subjec…
Depuy, Inc.1997—
*K983583Depuy Acromed Moss and Moss Miami Spinal Systems
Summary page 1
…pinal Fixation System (K070281) ISSYSTM Pedicle Screw System (K043522) Moss®k Miami Spinal System (K933881, K955348, K964024, K983583, K022623) Optima® Spinal System (K031t585) Device Description: The subject ISSYS L…
Depuy, Inc.1998—
*K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)
Summary page 1
…ISSYSTM Pedicle Screw System (K043522) Moss®k Miami Spinal System (K933881, K955348, K964024, K983583, K022623) Optima® Spinal System (K031t585) Device Description: The subject ISSYS LP Polyaxial Spinal Fixation Sys…
Depuyacromed2002—
*K031585U&I, Optima, Spinal SystemU&I Corp., America20035

Also cleared against K070281: 3 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K111099Issys LP Spinal Fixation SystemCustom Spine, Inc.20111
K113361Securis Spinal FixationCumtom Spine20120

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 28, 2013Class IIZ-1819-2013Process controlOn March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification. The screw length was 5 mm shorter in length than the required specification for the screw size. The product is…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
  • 3 of the 14 ancestors have a recall of any class.
  • Of its descendants, K111099 (Custom Spine, Inc., 2011) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K070281.

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. 2007, 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 ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows: For pedicular use: When used as pedicle screw fixation system of the non cervical posterior spine in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of…

Read the full statement (252 words)

The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

For pedicular use: When used as pedicle screw fixation system of the non cervical posterior spine 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, this system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 & 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.

When used as non pedicular fixation system:

The ISSYS LP Spinal Fixation System, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following:

• Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).

* Spondylolisthesis

* Fracture

* Spinal deformities such as scoliosis, kyphosis, lordosis

* Tumor

* Revision of failed fusion attempts

• Pseudarthrosis

* Spinal stenosis

When used in the anterior indication the ISSYS LP Spinal Fixation System are indicated for use in the thoracic and lumbar spine.

Indications for use as stated in the FDA summary.

Also cleared against K070281

3 other devices cite the same predicate.

  • K113361Securis Spinal FixationCumtom Spine · 2012
  • K111099Issys LP Spinal Fixation SystemCustom Spine, Inc. · 20111 recall
  • K073430Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008

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/K072866 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072866: Issys LP Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072866

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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