510(k) · Cleared
ClearedCam Lock Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Nov 20, 2015 as substantially equivalent to K070285 (Life Spine, 2007) and 2 other predicates after a 100-day review. Its family tree reaches back 5 generations to 1993. 1 later device descends from it.
- Decided
- Nov 20, 2015
- Review
- 100 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K926453 (1993). 24 ancestors in all, the oldest K792352 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
- 4 generations backK971883 Synthes Spine Small Stature Anterior Cervical Vertebrae Plate SystemSynthes (Usa) · 1997 · Recalled
- 3 generations backK063544 Modification to Pyrenees Cervical Plate SystemK2m, Inc. · 2007
- 2 generations backK113329 K2M, Pyrenees Cervical Plate SystemK2m, Inc. · 2012
- 1 generation backK130202 Iris Anterior Cervical PlateLife Spine, Inc. · 2013
- This deviceK152282 Cam Lock Plating SystemLife Spine, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK243369 Cervical Plating SystemLife Spine, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K243369Cervical Plating SystemLife Spine, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae Plate | Synthes (Usa) | 1993 | — |
| −4 | K971883 | Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System | Synthes (Usa) | 1997 | 1 |
| −3 | K063544 | Modification to Pyrenees Cervical Plate System | K2m, Inc. | 2007 | — |
| −2 | K113329 | K2M, Pyrenees Cervical Plate System | K2m, Inc. | 2012 | — |
| −1 | K130202 | Iris Anterior Cervical Plate | Life Spine, Inc. | 2013 | — |
| 0 (this device) | K152282 | Cam Lock Plating System | Life Spine, Inc. | 2015 | — |
| +1 | K243369 | Cervical Plating System | Life Spine, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 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 KWQ? 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? (3)
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 |
|---|---|---|---|
| * | K070285 | Life Spine Anterior Cervical Plate SystemSummary page 4…lassification: Class II Product Code: KWQ, Appliance, Fixation, Spinal Intervertebral Body Primary Predicate: Life Spine NEO SL ACP (K070285) Additional Predicates: Globus Providence ACP (K070775) The Life Spine IRIS ACP (K130202) Dev… | 2007 |
| * | K070775 | Modification to: Providence Anterior Cervical Plate SystemSummary page 4…KWQ, Appliance, Fixation, Spinal Intervertebral Body Primary Predicate: Life Spine NEO SL ACP (K070285) Additional Predicates: Globus Providence ACP (K070775) The Life Spine IRIS ACP (K130202) Device Description: The Life Spine Cam Lock Anterior Cervical P… | 2007 |
| * | K130202 | Iris Anterior Cervical PlateSummary page 4…ary Predicate: Life Spine NEO SL ACP (K070285) Additional Predicates: Globus Providence ACP (K070775) The Life Spine IRIS ACP (K130202) Device Description: The Life Spine Cam Lock Anterior Cervical Plating System consists of a variety of sizes of plates, screws… | 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 |
|---|---|---|---|
| K243369 | Cervical Plating 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 22 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 24 ancestors have a recall of any class.
- Of its descendants, K243369 (Life Spine, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K070285.
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. 2015, 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?
This system is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: 1.) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); 2). Spondylolisthesis; 3.) Trauma…
Read the full statement (109 words)
This system is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: 1.) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); 2). Spondylolisthesis; 3.) Trauma (including fractures or dislocations); 4.) Spinal cord stenosis; 5.) Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); 6.) Tumors; 7.) Pseudarthrosis; and/or 8.) Failed previous fusions.
Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152282 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152282: Cam Lock Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152282
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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