510(k) · Cleared
ClearedLospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa IS Rod- Pre Bent (Standard & BU
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corentec Co., Ltd. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Sep 19, 2013 as substantially equivalent to K092076 (Corentec Co., Ltd., 2010) and 10 other predicates after a 24-day review. Its family tree reaches back 14 generations to 1985.
- Decided
- Sep 19, 2013
- Review
- 24 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 14 generations to K853033 (1985). 182 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations between
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 1 generation backK130877 Expedium Spine SystemMedos International SARL · 2013
- This deviceK132644 Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod-…Corentec Co., Ltd. · 2013
Show all 14 generations
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 12 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 11 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 10 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 9 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 8 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 7 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 4 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 1 generation backK130877 Expedium Spine SystemMedos International SARL · 2013
- This deviceK132644 Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod-…Corentec Co., Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −13 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −12 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −11 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −10 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −9 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −8 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −7 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −4 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −3 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −2 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −1 | K130877 | Expedium Spine System | Medos International SARL | 2013 | — |
| 0 (this device) | K132644 | Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight… | Corentec Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 6 | 0 |
| 1997 | 7 | 0 |
| 1998 | 13 | 0 |
| 1999 | 10 | 0 |
| 2000 | 15 | 0 |
| 2001 | 11 | 0 |
| 2002 | 12 | 0 |
| 2003 | 12 | 0 |
| 2004 | 12 | 0 |
| 2005 | 12 | 0 |
| 2006 | 9 | 0 |
| 2007 | 6 | 0 |
| 2008 | 9 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 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 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? (11)
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 |
|---|---|---|---|
| * | K092076 | Aegis & Aegis II Spinal SystemSummary page 2…formities such as scoliosis, kyphosis. lordosis. tumor. pseuidarthrosis. or revision of failed fusion attempts. DEVICE DESCRIPTION LOSPA IS Spinal System cleared under K092076 is modified for inclusion of 5.5 diameter rods: The rod link (type -B) & pedicle screws are also modified to include 5.5 diameter… | 2010 |
| * | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…Summary page 3…AEGIS & AEGIS I1 Spinal Systems (Renamned cis LOSPA IS Spinal System) cleared uinder K092076, manufactured by Corentec Co., Ltd. * Synergy VLS cleared under K974749 (& K081952), manufactured by Rioimet Spine (Inierp~ore Cross hIternaljonal) * Moss Miami cleared under K022623(& K964… | 1998 |
| * | K081952 | Synergy Spinal System (6.35 Polaris)Summary page 3…GIS I1 Spinal Systems (Renamned cis LOSPA IS Spinal System) cleared uinder K092076, manufactured by Corentec Co., Ltd. * Synergy VLS cleared under K974749 (& K081952), manufactured by Rioimet Spine (Inierp~ore Cross hIternaljonal) * Moss Miami cleared under K022623(& K964024). manuf… | 2008 |
| * | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Summary page 3…tec Co., Ltd. * Synergy VLS cleared under K974749 (& K081952), manufactured by Rioimet Spine (Inierp~ore Cross hIternaljonal) * Moss Miami cleared under K022623(& K964024). manufactured by DePuy Acromed * OPTIMA cleared under K031585 (& K071880). manufactured by U & I Co… | 2002 |
| * | K964024 | Depuy Motech Titanium Moss Miami Spinal SystemSummary page 3…td. * Synergy VLS cleared under K974749 (& K081952), manufactured by Rioimet Spine (Inierp~ore Cross hIternaljonal) * Moss Miami cleared under K022623(& K964024). manufactured by DePuy Acromed * OPTIMA cleared under K031585 (& K071880). manufactured by U & I Corporation.… | 1997 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 3…ioimet Spine (Inierp~ore Cross hIternaljonal) * Moss Miami cleared under K022623(& K964024). manufactured by DePuy Acromed * OPTIMA cleared under K031585 (& K071880). manufactured by U & I Corporation. * Rogoziniski Spinal Rod System. cleared uinder K983904, manufactured… | 2003 |
| * | K071880 | Optima ZS Transition ScrewSummary page 3…Spine (Inierp~ore Cross hIternaljonal) * Moss Miami cleared under K022623(& K964024). manufactured by DePuy Acromed * OPTIMA cleared under K031585 (& K071880). manufactured by U & I Corporation. * Rogoziniski Spinal Rod System. cleared uinder K983904, manufactured by United… | 2007 |
| * | K983904 | Rogozinski Spinal Rod SystemSummary page 3…d by DePuy Acromed * OPTIMA cleared under K031585 (& K071880). manufactured by U & I Corporation. * Rogoziniski Spinal Rod System. cleared uinder K983904, manufactured by United Slates Surgical Corporation * APEX Spine System CoCr Rods, cleared under K 102488. manufactur… | 1998 |
| * | K102488 | Apex Spine System W/ Cocr RodsSummary page 3…* Rogoziniski Spinal Rod System. cleared uinder K983904, manufactured by United Slates Surgical Corporation * APEX Spine System CoCr Rods, cleared under K 102488. manufactured by SpineCrafl,LLC * Firebird Cobalt Chromec Rod, cleared under K092624, manufactured by B~lackst… | 2010 |
| * | K092624 | Firebird Spinal Fixation SystemSummary page 3…Surgical Corporation * APEX Spine System CoCr Rods, cleared under K 102488. manufactured by SpineCrafl,LLC * Firebird Cobalt Chromec Rod, cleared under K092624, manufactured by B~lackstone Medical. Inc. * EX1PEDI UM Spine System. cleared tinder K 130877. manufactured by DePuy… | 2009 |
| * | K130877 | Expedium Spine SystemSummary page 3…SpineCrafl,LLC * Firebird Cobalt Chromec Rod, cleared under K092624, manufactured by B~lackstone Medical. Inc. * EX1PEDI UM Spine System. cleared tinder K 130877. manufactured by DePuy PERFORMANCE DATA Corentec's LOSPA IS Spinal System modified components were subjected to a series of tes… | 2013 |
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 28 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 14 of the 182 ancestors have a recall of any class.
- 1 other device also cites its predicate K092076.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 LOSPA IS Spinal Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spandylolisthesis (grades 3 and 4) of the L5-SI vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation…
Read the full statement (133 words)
The LOSPA IS Spinal Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spandylolisthesis (grades 3 and 4) of the L5-SI vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion &pseudarthrosis).
When used as an anterior screw fixation system, the LOSPA IS Spinal Systems are indicated for patients with degener'ative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudaribrosis, or revision of failed fusion attempts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132644: Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa IS Rod- Pre Bent (Standard & BU.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132644
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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