510(k) · Cleared
ClearedPaeon Anterior Cervical Plate System, Elatus Lumbar Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aegis Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jan 11, 2023 as substantially equivalent to K221050 (Aegis Spine, Inc., 2022) and 5 other predicates after a 30-day review. Its family tree reaches back 19 generations to 1985. 1 of the 139 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Jan 11, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 19 generations to K853033 (1985). 135 ancestors in all. 3 later devices descend from it, 1 citing it directly. 1 of the 139 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 15 generations between
- 3 generations backK200793 LnK Posterior Cervical Fixation System and CastleLoc-S Posterior…L&K BIOMED Co., Ltd. · 2020
- 2 generations backK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
- 1 generation backK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
- This deviceK223719 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK231839 CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate…L&K BIOMED Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK261112 CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251940 PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2026
Show all 19 generations
- Root · 19 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 18 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 17 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 16 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 15 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 14 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 13 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 12 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 11 generations backK072568 Modification to Oasys SystemStryker Spine · 2007
- 10 generations backK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
- 9 generations backK093670 Modification to: Oasys SystemStryker Spine · 2010 · Recalled (Class I)
- 8 generations backK111719 Oasys Spinal SystemStryker Spine · 2012
- 7 generations backK142741 OASYS SystemStryker Corporation · 2015
- 6 generations backK150753 OASYS SystemStryker Corporation · 2015
- 5 generations backK151755 OASYS (r) SystemStryker Corporation · 2015
- 4 generations backK162136 CastleLoc-S Posterior Cervical Fixation System; LnK Posterior…L&K BIOMED Co., Ltd. · 2016
- 3 generations backK200793 LnK Posterior Cervical Fixation System and CastleLoc-S Posterior…L&K BIOMED Co., Ltd. · 2020
- 2 generations backK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
- 1 generation backK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
- This deviceK223719 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023
Class I recalls in this family
- K093670 Modification to: Oasys System8 generations back · 2010
Most influential descendants
Showing 3 of 3 · See all- K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2023 · cites it directly2descendants
- K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026 · 2 generations on0descendants
- K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −18 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −17 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −16 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −15 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −14 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −13 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −12 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −11 | K072568 | Modification to Oasys System | Stryker Spine | 2007 | — |
| −10 | K080143 | Modification to Stryker Spine Oasys System | Stryker Spine | 2008 | — |
| −9 | K093670 | Modification to: Oasys System | Stryker Spine | 2010 | Class I |
| −8 | K111719 | Oasys Spinal System | Stryker Spine | 2012 | — |
| −7 | K142741 | OASYS System | Stryker Corporation | 2015 | — |
| −6 | K150753 | OASYS System | Stryker Corporation | 2015 | — |
| −5 | K151755 | OASYS (r) System | Stryker Corporation | 2015 | — |
| −4 | K162136 | CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical… | L&K BIOMED Co., Ltd. | 2016 | — |
| −3 | K200793 | LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical… | L&K BIOMED Co., Ltd. | 2020 | — |
| −2 | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System… | Aegis Spine | 2021 | — |
| −1 | K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon… | Aegis Spine, Inc. | 2022 | — |
| 0 (this device) | K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System | Aegis Spine, Inc. | 2023 | — |
| +1 | K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | 2023 | — |
| +2 | K261112 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2026 | — |
| +2 | K251940 | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 4 | 0 |
| 2005 | 7 | 0 |
| 2006 | 10 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 7 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 2 | 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.
1 device in this family has a Class I recall. 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Summary page 5…te devices in all characteristics. Subject Device Name 510K NO. Trade or Proprietary or Model Name Predicate Type PAEON Anterior K 221050 Paeon Anterior Cervical Plate System, Primary Cervical Plate System Spinema Lumbar Plate System.… | 2022 |
| * | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Summary page 5…K 221050 Paeon Anterior Cervical Plate System, Primary Cervical Plate System Spinema Lumbar Plate System. K 210035 Paeon Anterior Cervical Plate System, Additional Spinema Lumbar Plate System… | 2021 |
| * | K143271 | CastleLoc-P Anterior Cervical Plate SystemSummary page 5…210035 Paeon Anterior Cervical Plate System, Additional Spinema Lumbar Plate System. K 143271 CastleLoc Anterior Plate System Additional K 190425 Elatus Lumbar Plate… | 2015 |
| * | K190425 | CastleLoc-P Anterior Cervical Plate SystemSummary page 5…Spinema Lumbar Plate System. K 143271 CastleLoc Anterior Plate System Additional K 190425 Elatus Lumbar Plate K 221050 Paeon Anterior Cervical Plate System, Primary System… | 2019 |
| * | K142699 | LITe Plate SystemSummary page 5…210035 Paeon Anterior Cervical Plate System, Additional Spinema Lumbar Plate System. K 142699 LITe Plate System Additional K 143626 Trinica® Anterior Lumbar Pl… | 2014 |
| * | K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…Summary page 5…Spinema Lumbar Plate System. K 142699 LITe Plate System Additional K 143626 Trinica® Anterior Lumbar Plate System Additional… | 2015 |
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 |
|---|---|---|---|
| K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | 2023 | 2 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K093670Modification to: Oasys SystemStryker Spine · 2010 · 8 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 38 years and passes through 10 companies; a new generation was cleared every 1.3 years on median.
- 14 of the 135 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K231839 (L&K BIOMED Co., Ltd., 2023) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K221050.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The Paeon Anterior Cervical Plate System is intended for anterior to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors…
Read the full statement (193 words)
The Paeon Anterior Cervical Plate System is intended for anterior to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:
• degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
• spondylolisthesis,
• trauma (i.e. fractures or dislocations),
• tumors,
• deformity (defined as kyphosis, lordosis, or scoliosis),
• pseudoarthrosis,
• failed previous fusion,
• spinal stenosis.
The Elatus Lumbar Plate System is indicated for use via the anterior, lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223719 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223719: Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223719
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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