510(k) · Cleared
ClearedCB PROT II Posterior Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chin Bone Technique Corp · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jan 26, 2015 as substantially equivalent to K111883 (A-Spine Asia, Co., Ltd., 2011) after a 130-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Jan 26, 2015
- Review
- 130 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K901587 (1990). 35 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 6 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 5 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 4 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 3 generations backK100377 Diamondback Spinal SystemEminent Spine · 2010
- 2 generations backK102853 Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG · 2011 · Recalled
- 1 generation backK111883 Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd. · 2011
- This deviceK142655 CB PROT II Posterior Spinal SystemChin Bone Technique Corp · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −6 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −5 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −4 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −3 | K100377 | Diamondback Spinal System | Eminent Spine | 2010 | — |
| −2 | K102853 | Flamenco Spinal Fixation System | Ulrich GmbH & Co. KG | 2011 | 1 |
| −1 | K111883 | Smartloc Spinal Fixation System | A-Spine Asia, Co., Ltd. | 2011 | — |
| 0 (this device) | K142655 | CB PROT II Posterior Spinal System | Chin Bone Technique Corp | 2015 | — |
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 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 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
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K111883 | Smartloc Spinal Fixation SystemSummary page 4…crew system Classification Name: Pedicle screw spinal system Regulation Number: 21 CFR 888.3070 Predicate Devices: SmartLocTM spinal fixation system (K111883) Material: The CB PROT II Posterior Spinal System components are manufactured from… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 35 ancestors have a recall of any class.
- 1 other device also cites its predicate K111883.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CB PROT II Posterior Spinal System is intended to provide immobilization and stabilization for posterior, non-cervical, pedicle fixation of the thoracic, lumbar and sacral spinal elements (T1-S1) as an adjunct to fusion for the following indications:
- Trauma (i.e. fracture or dislocation).
- Spinal stenosis.
- Vertebral tumors.
- Pseudoarthrosis and failed previous fusion in skeletally mature patients.
- Scoliosis, kyphosis and lordosis, and severe spondylolisthesis (grade 3 or 4) of the T1-S1 vertebra.
The system is intended to be used with autograft or allograft to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142655: CB PROT II Posterior Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142655
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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