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 Apr 19, 2013 as substantially equivalent to K111301 (Zimmer Spine, 2011) and 4 other predicates after a 151-day review. Its family tree reaches back 7 generations to 2000. It has been recalled once.
- Decided
- Apr 19, 2013
- Review
- 151 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 7 generations to K992147 (2000). 55 ancestors in all, the oldest K901587 (1990). No later device cites it as a predicate yet.
- Root · 7 generations backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
- 6 generations backK001668 Global Spinal Fixation SystemD.K.M. Co., Ltd. · 2000
- 5 generations backK031455 Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003
- 4 generations backK070933 Lowtop Pedicle Screw SystemSanacor · 2007
- 3 generations backK072187 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007
- 2 generations backK080518 Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008
- 1 generation backK100297 Pass LP Spinal SystemMedicrea Technologies · 2010
- This deviceK123552 Instinct Java SystemZimmer Spine · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K992147 | Triple-Fix Spinal Fixation System | Advanced Spine Technology, Inc. | 2000 | — |
| −6 | K001668 | Global Spinal Fixation System | D.K.M. Co., Ltd. | 2000 | — |
| −5 | K031455 | Conklusion Pedicle Screw System | Signus Medical, LLC | 2003 | — |
| −4 | K070933 | Lowtop Pedicle Screw System | Sanacor | 2007 | — |
| −3 | K072187 | Pioneer Lowtop Spinal Rod System | Pioneer Surgical Technology | 2007 | — |
| −2 | K080518 | Pioneer Surgical Technology Quantum Spinal System | Pioneer Surgical Technology | 2008 | — |
| −1 | K100297 | Pass LP Spinal System | Medicrea Technologies | 2010 | — |
| 0 (this device) | K123552 | Instinct Java System | Zimmer Spine | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 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? (5)
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 |
|---|---|---|---|
| * | K111301 | Instinct Java System | 2011 |
| * | K113270 | Instinct Java SystemSummary page 1…vice Classification: Class Ill Predicate Devices: Zimmer Spine Instinct m Javao' System, Kil1301, K1 13270 Zimmer Spine Sequoia Spinal System, K082032 Medicrea… | 2011 |
| * | K082032 | Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309…Summary page 1…Zimmer Spine Instinct m Javao' System, Kil1301, K1 13270 Zimmer Spine Sequoia Spinal System, K082032 Medicrea PASS LP Spinal System, K100297 Medtronic CID… | 2008 |
| * | K100297 | Pass LP Spinal SystemSummary page 1…K1 13270 Zimmer Spine Sequoia Spinal System, K082032 Medicrea PASS LP Spinal System, K100297 Medtronic CID Horizon, K121764 Description of Device: The Instinct Java System is a tempor… | 2010 |
| * | K121764 | CD Horizon Spinal SystemSummary page 1…Sequoia Spinal System, K082032 Medicrea PASS LP Spinal System, K100297 Medtronic CID Horizon, K121764 Description of Device: The Instinct Java System is a temporary implant system used to correct spinal deformity in skeletally mat… | 2012 |
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
| 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 13 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 6 of the 55 ancestors have a recall of any class.
- 2 other devices also cite its predicate K111301.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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, kyphotic 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/K123552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123552: 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/K123552
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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