510(k) · Cleared
Recalled · Class II · 2016Instinct Java System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Spine · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Aug 26, 2011 as substantially equivalent to K082032 (Abbott Spine, Inc., 2008) and 2 other predicates after a 109-day review. Its family tree reaches back 5 generations to 1990. 3 later devices descend from it. It has been recalled once.
- Decided
- Aug 26, 2011
- Review
- 109 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K901587 (1990). 29 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 4 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 3 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 2 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 1 generation backK100377 Diamondback Spinal SystemEminent Spine · 2010
- This deviceK111301 Instinct Java SystemZimmer Spine · 2011
- Descendant · cites it directly · 2 of its ownK113270 Instinct Java SystemZimmer Spine · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK123552 Instinct Java SystemZimmer Spine · 2013 · Recalled
- Descendant · cites it directly · 0 of its ownK122592 Instinct Java SystemZimmer Spine · 2013 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −4 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −3 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −2 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −1 | K100377 | Diamondback Spinal System | Eminent Spine | 2010 | — |
| 0 (this device) | K111301 | Instinct Java System | Zimmer Spine | 2011 | — |
| +1 | K113270 | Instinct Java System | Zimmer Spine | 2011 | 1 |
| +1 | K123552 | Instinct Java System | Zimmer Spine | 2013 | 1 |
| +1 | K122592 | Instinct Java System | Zimmer Spine | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
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 NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K082032 | Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309…Summary page 1…gulation Number: 888.3070 Device Classification: Class Ill Predicate Devices: Zimmer Spine Sequoia® Spinal System. K082032 Zimmer Spine Silhouette® Spinal System, K042702 Diamo… | 2008 |
| * | K042702 | Silhouette Spinal Fixation SystemSummary page 1…ass Ill Predicate Devices: Zimmer Spine Sequoia® Spinal System. K082032 Zimmer Spine Silhouette® Spinal System, K042702 Diamondback Spinal System, K1 00377 Description of Device: The Instinct Java System is a… | 2004 |
| * | K100377 | Diamondback Spinal SystemSummary page 1…al System. K082032 Zimmer Spine Silhouette® Spinal System, K042702 Diamondback Spinal System, K1 00377 Description of Device: The Instinct Java System is a temporary implant system used to correct spinal deformity in skeletally ma… | 2010 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 12, 2016 | Class II | Z-1190-2016 | Process control | Zimmer 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 21 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 29 ancestors have a recall of any class.
- Of its descendants, K113270 (Zimmer Spine, 2011) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K082032.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
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, kylphotic or lordotic spinal deformities, scoliosis, tumor and pseudloarthrosis, or for revision of a failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111301: 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/K111301
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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