510(k) · Cleared
ClearedLOSPA® IS™ Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corentec Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 6, 2020 as substantially equivalent to K092076 (Corentec Co., Ltd., 2010) and 9 other predicates after a 32-day review. Its family tree reaches back 15 generations to 1985. 1 later device descends from it.
- Decided
- Mar 6, 2020
- Review
- 32 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 15 generations to K853033 (1985). 266 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations between
- 3 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 2 generations backK133575 Spinevision Lumis Cannulated Pedicle Screw Fixation System…Spinevision S.A. · 2014
- 1 generation backK160124 LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle…Spinevision S.A. · 2016
- This deviceK200267 LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK240180 Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd. · 2024
Show all 15 generations
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 14 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 13 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 12 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 11 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 10 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 9 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 8 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 7 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 6 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 4 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 3 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 2 generations backK133575 Spinevision Lumis Cannulated Pedicle Screw Fixation System…Spinevision S.A. · 2014
- 1 generation backK160124 LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle…Spinevision S.A. · 2016
- This deviceK200267 LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −14 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −13 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −12 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −11 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −10 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −9 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −8 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −7 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −6 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −4 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −3 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −2 | K133575 | Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision… | Spinevision S.A. | 2014 | — |
| −1 | K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw… | Spinevision S.A. | 2016 | — |
| 0 (this device) | K200267 | LOSPA® IS™ Spinal Fixation System | Corentec Co., Ltd. | 2020 | — |
| +1 | K240180 | Orthopeasia Spinal Fixation System | Orthopeasia Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 9 | 0 |
| 1996 | 8 | 0 |
| 1997 | 7 | 0 |
| 1998 | 16 | 0 |
| 1999 | 12 | 0 |
| 2000 | 21 | 0 |
| 2001 | 19 | 0 |
| 2002 | 12 | 0 |
| 2003 | 12 | 0 |
| 2004 | 18 | 0 |
| 2005 | 22 | 0 |
| 2006 | 15 | 0 |
| 2007 | 12 | 0 |
| 2008 | 14 | 0 |
| 2009 | 10 | 0 |
| 2010 | 13 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K092076 | Aegis & Aegis II Spinal SystemSummary page 5…AEGIS & AEGIS II Spinal Systems componen Predicate Corentec Co., Ltd. (Renamed as LOSPA IS Spinal K092076 ts System) Additional Stryker Xia 3 Spinal System… | 2010 |
| * | K071373 | Stryker Spine Xia Iii Spinal SystemSummary page 5…IS Spinal K092076 ts System) Additional Stryker Xia 3 Spinal System K071373(T), Pedicle Corentec Co., Ltd… | 2007 |
| * | K083393 | Xia 3 Spinal SystemSummary page 6…cification Inclusion Rhino™ Percutaneous Pedicle Screw Predicate K083393(T), Screws K091291(S) L&K BIOM… | 2009 |
| * | K091291 | Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodSummary page 6…K083393(T), Screws K091291(S) L&K BIOMED LnK Spinal Fixation system K143363… | 2009 |
| * | K143363 | VENUS Spinal Fixation SystemSummary page 6…K091291(S) L&K BIOMED LnK Spinal Fixation system K143363 SpineVision LUMIS™ Cannulated Pedicle Screw F… | 2015 |
| * | K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSummary page 6…MIS™ Cannulated Pedicle Screw Fixation System, SpineVision, S.A. K160124 Cannulate SpineVision U.L.I.S.™ Pedicle… | 2016 |
| * | K110283 | Zenius Spinal SystemSummary page 6…Screws MEDYSSEY CO., ZENIUS SPINAL SYSTEM K110283 LTD. EXPEDIUM VERSE SPINE DePuy Synthes… | 2011 |
| * | K142185 | Expedium Verse Spine SystemSummary page 6…10283 LTD. EXPEDIUM VERSE SPINE DePuy Synthes K142185 SYSTEM MIS L&K Biomed Co.… | 2014 |
| * | K183117 | PathLoc-L MIS Spinal SystemSummary page 6…SYSTEM MIS L&K Biomed Co., K183117 screws PathLoc-L MIS Spinal System Ltd.… | 2018 |
| * | K161766 | PathLoc-L MIS Spinal SystemSummary page 6…117 screws PathLoc-L MIS Spinal System Ltd. (K161766) The LOSPA IS Spinal Fixation System is similar to the cleared devices as mentioned above with respect to indications, design, o… | 2016 |
| † | K132644 | Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240180 | Orthopeasia Spinal Fixation System | 2024 | 0 |
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 35 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 20 of the 266 ancestors have a recall of any class.
- Of its descendants, K240180 (Orthopeasia Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K092076.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 LOSPA IS Spinal Fixation 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 spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture…
Read the full statement (134 words)
The LOSPA IS Spinal Fixation 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 spondylolisthesis (grades 3 and 4) of the L5-S1 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 Spinal Fixation Systems are indicated for patients with degenerative 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, pseudoarthrosis, or revision of failed fusion attempts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200267: LOSPA® IS™ 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/K200267
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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