510(k) · Cleared
ClearedSmartloc Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A-Spine Asia, Co., Ltd. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Oct 18, 2011 as substantially equivalent to K031655 (Medtronic Sofamor Danek USA, Inc., 2003) and 9 other predicates after a 109-day review. Its family tree reaches back 6 generations to 1990. 2 later devices descend from it.
- Decided
- Oct 18, 2011
- Review
- 109 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 6 generations to K901587 (1990). 34 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 5 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 4 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 3 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 2 generations backK100377 Diamondback Spinal SystemEminent Spine · 2010
- 1 generation backK102853 Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG · 2011 · Recalled
- This deviceK111883 Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK252730 Fule Spinal Fixation SystemBeijing Fule Science & Technology Development Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK142655 CB PROT II Posterior Spinal SystemChin Bone Technique Corp · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −5 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −4 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −3 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −2 | K100377 | Diamondback Spinal System | Eminent Spine | 2010 | — |
| −1 | K102853 | Flamenco Spinal Fixation System | Ulrich GmbH & Co. KG | 2011 | 1 |
| 0 (this device) | K111883 | Smartloc Spinal Fixation System | A-Spine Asia, Co., Ltd. | 2011 | — |
| +1 | K252730 | Fule Spinal Fixation System | Beijing Fule Science & Technology Development Co., Ltd. | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2025 | 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 MNI? 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? (10)
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 |
|---|---|---|---|
| * | K031655 | CD Horizon Spinal SystemSummary page 2…LocrM components are manufactured from titanium alloy (Ti-6A1-4V) as described by ISO 5832-3 / ASTM F136. Predicate Devices: CD HORIZON®b (K031655/K041460) Moss Miami (K992168/K022623) Synergy VLS (K950099/K974749)… | 2003 |
| * | K041460 | CD Horizon Spinal SystemSummary page 2…mponents are manufactured from titanium alloy (Ti-6A1-4V) as described by ISO 5832-3 / ASTM F136. Predicate Devices: CD HORIZON®b (K031655/K041460) Moss Miami (K992168/K022623) Synergy VLS (K950099/K974749)… | 2004 |
| * | K992168 | Moss Miami 6.35MM Polyaxial ScrewSummary page 2…alloy (Ti-6A1-4V) as described by ISO 5832-3 / ASTM F136. Predicate Devices: CD HORIZON®b (K031655/K041460) Moss Miami (K992168/K022623) Synergy VLS (K950099/K974749) Optima7M (K024096/K<031585/K<051971)… | 1999 |
| * | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Summary page 2…alloy (Ti-6A1-4V) as described by ISO 5832-3 / ASTM F136. Predicate Devices: CD HORIZON®b (K031655/K041460) Moss Miami (K992168/K022623) Synergy VLS (K950099/K974749) Optima7M (K024096/K<031585/K<051971)… | 2002 |
| * | K950099 | Synergy (TM) TI Posterior Spinal SystemSummary page 2…O 5832-3 / ASTM F136. Predicate Devices: CD HORIZON®b (K031655/K041460) Moss Miami (K992168/K022623) Synergy VLS (K950099/K974749) Optima7M (K024096/K<031585/K<051971) flamenco (K102853) Technological… | 1997 |
| * | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…Summary page 2…/ ASTM F136. Predicate Devices: CD HORIZON®b (K031655/K041460) Moss Miami (K992168/K022623) Synergy VLS (K950099/K974749) Optima7M (K024096/K<031585/K<051971) flamenco (K102853) Technological… | 1998 |
| * | K024096 | Optima, Spinal SystemSummary page 2…RIZON®b (K031655/K041460) Moss Miami (K992168/K022623) Synergy VLS (K950099/K974749) Optima7M (K024096/K<031585/K<051971) flamenco (K102853) Technological The SmartLocTM possesses the same technol… | 2003 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 2…031655/K041460) Moss Miami (K992168/K022623) Synergy VLS (K950099/K974749) Optima7M (K024096/K<031585/K<051971) flamenco (K102853) Technological The SmartLocTM possesses the same technological Ch… | 2003 |
| * | K051971 | Optima Spinal SystemSummary page 2…41460) Moss Miami (K992168/K022623) Synergy VLS (K950099/K974749) Optima7M (K024096/K<031585/K<051971) flamenco (K102853) Technological The SmartLocTM possesses the same technological Characteris… | 2005 |
| * | K102853 | Flamenco Spinal Fixation SystemSummary page 2…(K992168/K022623) Synergy VLS (K950099/K974749) Optima7M (K024096/K<031585/K<051971) flamenco (K102853) Technological The SmartLocTM possesses the same technological Characteristics: characteristics as the predica… | 2011 |
What descends from it? (2)
2 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)
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 21 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 34 ancestors have a recall of any class.
- Of its descendants, K252730 (Beijing Fule Science & Technology Development Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 24 other devices also cite its predicate K031655.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SmartLoc TM is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L_5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (Ti to…
Read the full statement (171 words)
The SmartLoc TM is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L_5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (Ti to S2), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kylphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients. When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., nonpedicle screw), the SmarLocTM is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111883: Smartloc Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111883
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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