510(k) · Cleared
ClearedIbis® Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Development Corporation · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 30, 2017 as substantially equivalent to K142146 (Ortho Development Corp., 2014) and 2 other predicates after a 154-day review. Its family tree reaches back 14 generations to 1999. 3 later devices descend from it.
- Decided
- Mar 30, 2017
- Review
- 154 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K990745 (1999). 154 ancestors in all, the oldest K853033 (1985). 3 later devices descend from it, 1 citing it directly.
- Root · 14 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 10 generations between
- 3 generations backK113058 Tiger Spine SystemCorelink, LLC · 2012
- 2 generations backK131785 Pagoda Pedicle Screw SystemOrtho Development Corp. · 2013
- 1 generation backK142146 Ibis Pedicle Screw SystemOrtho Development Corp. · 2014
- This deviceK162995 Ibis® Pedicle Screw SystemOrtho Development Corporation · 2017
- Descendant · cites it directly · 2 of its ownK161225 Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK180226 TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK240233 Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2024
Show all 14 generations
- Root · 14 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 13 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 12 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 11 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 10 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 9 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 8 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 7 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 6 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 5 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 4 generations backK110906 Apex Spine SystemSpinecraft, LLC · 2011
- 3 generations backK113058 Tiger Spine SystemCorelink, LLC · 2012
- 2 generations backK131785 Pagoda Pedicle Screw SystemOrtho Development Corp. · 2013
- 1 generation backK142146 Ibis Pedicle Screw SystemOrtho Development Corp. · 2014
- This deviceK162995 Ibis® Pedicle Screw SystemOrtho Development Corporation · 2017
Most influential descendants
Showing 3 of 3 · See all- K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd. · 2017 · cites it directly2descendants
- K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd. · 2018 · 2 generations on1descendant
- K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −13 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −12 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −11 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −10 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −9 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −8 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −7 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −6 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −5 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| −4 | K110906 | Apex Spine System | Spinecraft, LLC | 2011 | — |
| −3 | K113058 | Tiger Spine System | Corelink, LLC | 2012 | — |
| −2 | K131785 | Pagoda Pedicle Screw System | Ortho Development Corp. | 2013 | — |
| −1 | K142146 | Ibis Pedicle Screw System | Ortho Development Corp. | 2014 | — |
| 0 (this device) | K162995 | Ibis® Pedicle Screw System | Ortho Development Corporation | 2017 | — |
| +1 | K161225 | Paonan Armstrong Posterior Spinal Fixation System | Paonan Biotech Co., Ltd. | 2017 | — |
| +2 | K180226 | TREND II Spinal Fixation System- STEP Series | Paonan Biotech Co., Ltd. | 2018 | — |
| +3 | K240233 | Pitkar Spinal Pedicle Screw System | S.H.Pitkar Orthotools Pvt., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 0 |
| 1997 | 7 | 0 |
| 1998 | 10 | 0 |
| 1999 | 8 | 0 |
| 2000 | 10 | 0 |
| 2001 | 10 | 0 |
| 2002 | 4 | 0 |
| 2003 | 8 | 0 |
| 2004 | 15 | 0 |
| 2005 | 10 | 0 |
| 2006 | 9 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 6 | 0 |
| 2010 | 6 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K142146 | Ibis Pedicle Screw SystemSummary page 4…21 CFR 888.3070 Device Product Code: NKB Class: Class II Primary Predicate Device: Ibis® Pedicle Screw System (K142146) Ortho Development Corporation Additional Predicate Devices: Pagoda® Pedicle Screw System… | 2014 |
| * | K131785 | Pagoda Pedicle Screw SystemSummary page 4…Ibis® Pedicle Screw System (K142146) Ortho Development Corporation Additional Predicate Devices: Pagoda® Pedicle Screw System (K131785) Ortho Development Corporation Additions to the EXPEDIUM® an… | 2013 |
| * | K101993 | Viper System, Expedium SystemSummary page 4…Screw System (K131785) Ortho Development Corporation Additions to the EXPEDIUM® and VIPER® Systems (K101993) Depuy Spine, Inc Description The Ibis® Pedicle Screw System consists of bulleted rods; cannu… | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161225 | Paonan Armstrong Posterior Spinal Fixation System | 2017 | 2 |
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?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 154 ancestors have a recall of any class.
- Of its descendants, K161225 (Paonan Biotech Co., Ltd., 2017) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K142146.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Ibis® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft or allograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1 – Sacrum/Ileum) for the following indications: 1) Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of…
Read the full statement (110 words)
The Ibis® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft or allograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1 – Sacrum/Ileum) for the following indications:
1) Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
2) Degenerative Spondylolisthesis with objective evidence of neurologic impairment
3) Trauma (fracture or dislocation)
4) Spinal tumor
5) Failed previous fusion (pseudarthrosis)
6) Spinal stenosis
7) Spinal deformities or curvatures such as scoliosis, kyphosis, or lordosis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162995: Ibis® Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162995
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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