510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Instinct Java System

K122592510(k) TraditionalCleared Jan 4, 2013133-day reviewClass II21 CFR 888.3070Recalls 1

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

Zimmer Spine · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Jan 4, 2013 as substantially equivalent to K111301 (Zimmer Spine, 2011) and 5 other predicates after a 133-day review. Its family tree reaches back 12 generations to 2004. It has been recalled once.

Decided
Jan 4, 2013
Review
133 days
Class
Class II
Product code
MNH
Recalls
1
Predicates
6

Its longest line of descent runs back 12 generations to K040583 (2004). 102 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 3 other ancestors2008: 4 other ancestors2010: 2 other ancestors2007: 3 other ancestors2004: 16 other ancestors2009: 1 other ancestor2006: 5 other ancestors2005: 8 other ancestors2003: 6 other ancestors2002: 6 other ancestors2000: 5 other ancestors1999: 2 other ancestors1998: 5 other ancestors1997: 2 other ancestors2001: 6 other ancestors1996: 2 other ancestors1995: 2 other ancestors1994: 2 other ancestors1993: 2 other ancestors1992: 5 other ancestors1990: 2 other ancestors1984: 1 other ancestorReference device: K062505 · Nex-Link Spinal Fixation System Offset Connectors, 2121-XX Series · Abbott Spine, Inc. · 2006Reference device: K060634 · Nex-Link Spinal Fixation System Rod to Rod Connectors, Models 725, 726 Series · Abbott Spine, Inc. · 2006 · recalledReference device: K052566 · Nex-Link Spinal Fixation System Open Polyaxial Screws, Models 2112, 2113, 2118, 2119, 2120. Nex-Link Spinal Fixation SY · Abbott Spine, Inc. · 2006 · recalledReference device: K052247 · Nex-Link Spinal Fixation System Variable Crosslink, Model 721-XX · Abbott Spine, Inc. · 2005 · recalledReference device: K031985 · Spinal Concepts Inc. Nex-Link Spinal Fixation System · Spinal Concepts, Inc. · 2003 · recalled×3: 3 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004) K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005×2: 2 generations cleared close together, K050809 (2005), K052187 (2005) K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) 19801985199019952000200520102015
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors3 generations back: 25 other ancestors4 generations back: 34 other ancestors5 generations back: 11 other ancestors6 generations back: 10 other ancestors K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−10−50
  1. Root · 12 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 8 generations between
  3. 3 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  4. 2 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  5. 1 generation backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  6. This deviceK122592 Instinct Java SystemZimmer Spine · 2013
Show all 12 generations
  1. Root · 12 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 11 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 10 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 9 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 8 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 7 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 6 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 5 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 4 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 3 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 2 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 1 generation backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. This deviceK122592 Instinct Java SystemZimmer Spine · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−11K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−10K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−9K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−8K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−7K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−6K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−5K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−4K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−3K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−2K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−1K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
0 (this device)K122592Instinct Java SystemZimmer Spine2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199020
199250
199320
199420
199520
199620
199720
199850
199920
200050
200160
200260
200360
2004160
200580
200650
200730
200840
200910
201020
201130
FIG. 1 — Lineage of K122592, 2004–2013Source: 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 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
Get a 510(k) Report

What was it cleared against? (6)

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
*K111301Instinct Java System
Summary page 1
…ulation Number: 888.3070 Device Classification: Class Ill Predicate Devices: Zimmer Spine lnstinctTM Java® System, K1 11301, K1 13270 Zimmer Spine Sequoia Spinal System, K082032…
Zimmer Spine20111
*K113270Instinct Java System
Summary page 1
…ice Classification: Class Ill Predicate Devices: Zimmer Spine lnstinctTM Java® System, K1 11301, K1 13270 Zimmer Spine Sequoia Spinal System, K082032 Medtronic…
Zimmer Spine20111
*K082032Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309…
Summary page 1
…Zimmer Spine lnstinctTM Java® System, K1 11301, K1 13270 Zimmer Spine Sequoia Spinal System, K082032 Medtronic CID Horizon Solera System, K1 12473, K1 131…
Abbott Spine, Inc.20081
*K112473CD Horizon Spinal System
Summary page 1
…K1 13270 Zimmer Spine Sequoia Spinal System, K082032 Medtronic CID Horizon Solera System, K1 12473, K1 13174 Zimmer Spine Title 2 Potyaxial Spinal Syste…
Medtronic Sofamor Danek, Inc.2011—
*K113174CD Horizon Spinal System
Summary page 1
…Zimmer Spine Sequoia Spinal System, K082032 Medtronic CID Horizon Solera System, K1 12473, K1 13174 Zimmer Spine Title 2 Potyaxial Spinal System, K07351…
Medtronic Sofamor Danek USA, Inc.20111
*K073510Endius Title 2 Poly Axial Spinal System
Summary page 1
…K1 13174 Zimmer Spine Title 2 Potyaxial Spinal System, K07351 0 Description of Device: The Instinct Java System is a temporary implant system used to correct spinal deformity in skeletally mat…
Endius, Inc.2008—
†K062505Nex-Link Spinal Fixation System Offset Connectors, 2121-XX SeriesAbbott Spine, Inc.2006—
†K060634Nex-Link Spinal Fixation System Rod to Rod Connectors, Models 725, 726 SeriesAbbott Spine, Inc.20064
†K052566Nex-Link Spinal Fixation System Open Polyaxial Screws, Models 2112, 2113, 2118, 2119…Abbott Spine, Inc.20064
†K052247Nex-Link Spinal Fixation System Variable Crosslink, Model 721-XXAbbott Spine, Inc.20054
†K031985Spinal Concepts Inc. Nex-Link Spinal Fixation SystemSpinal Concepts, Inc.20034

Also cleared against K111301: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 12, 2016Class IIZ-1190-2016Process controlZimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct¿ Java¿ System (IFU reference: 046WAN0000T) and Universal Clamp¿ System (IFU reference…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 4 months on median.
  • 14 of the 102 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K111301.

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. 2013, this device’s year, is highlighted.

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—

What is it indicated for?

The Instinct Java spinal fixation system is designed for spinal fixation procedures in skeletally mature patients performed through a posterior approach. The Instinct Java spinal fixation system is indicated for the temporary realignment and stabilization of one or more intervertebral segments from the thoracic spine to the sacrum until bony fusion is obtained. The Instinct Java spinal fixation system is indicated to achieve bony fusion via…

Read the full statement (120 words)

The Instinct Java spinal fixation system is designed for spinal fixation procedures in skeletally mature patients performed through a posterior approach.

The Instinct Java spinal fixation system is indicated for the temporary realignment and stabilization of one or more intervertebral segments from the thoracic spine to the sacrum until bony fusion is obtained.

The Instinct Java spinal fixation system is indicated to achieve bony fusion via osteosynthesis at thoracic, lumbar and/or lumbosacral levels of the spine in documented cases of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, kyphotic or lordlotic spinal deformities, scoliosis, tumor and pseudloarthrosis, or for revision of a failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K111301

2 other devices cite the same predicate.

  • K123552Instinct Java SystemZimmer Spine · 20131 recall
  • K113270Instinct Java SystemZimmer Spine · 20111 recall

More from Zimmer Spine

5 FDA decisions under this applicant name. See the company

  • K123552Instinct Java SystemZimmer Spine · 20131 recall
  • K113270Instinct Java SystemZimmer Spine · 20111 recall
  • K111301Instinct Java SystemZimmer Spine · 20111 recall
  • K110348Universal Clamp Spinal Fixation SystemZimmer Spine · 2011

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/K122592 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122592: Instinct Java System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122592

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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