510(k) · Cleared
ClearedAccuFit Lateral Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Nov 28, 2016 as substantially equivalent to K133194 (Eminent Spine, 2014) and 2 other predicates after a 112-day review. Its family tree reaches back 5 generations to 1993. 4 later devices descend from it.
- Decided
- Nov 28, 2016
- Review
- 112 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K922543 (1993). 18 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
- 4 generations backK013665 Pyramid Anterior Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 3 generations backK043548 Blackstone Unity Anterior Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2005
- 2 generations backK061229 Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc. · 2006
- 1 generation backK070922 Modification to Spinal Usa VBR SystemSpinal USA · 2007
- This deviceK162211 AccuFit Lateral Plate SystemPrecision Spine, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK220324 AccuFit Lateral 2-Hole PlatePrecision Spine, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK241468 Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK261810 Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
- Descendant · cites it directly · 0 of its ownK232256 Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024
Most influential descendants
Showing 4 of 4 · See all- K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc. · 2022 · cites it directly3descendants
- K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024 · 2 generations on1descendant
- K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026 · 3 generations on0descendants
- K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922543 | Z-Plate Anterior Fixation System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −4 | K013665 | Pyramid Anterior Plate Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −3 | K043548 | Blackstone Unity Anterior Lumbar Plate Fixation System | Blackstone Medical, Inc. | 2005 | — |
| −2 | K061229 | Unity LX Anterolateral Lumbar Plate Fixation System | Blackstone Medical, Inc. | 2006 | — |
| −1 | K070922 | Modification to Spinal Usa VBR System | Spinal USA | 2007 | — |
| 0 (this device) | K162211 | AccuFit Lateral Plate System | Precision Spine, Inc. | 2016 | — |
| +1 | K220324 | AccuFit Lateral 2-Hole Plate | Precision Spine, Inc. | 2022 | — |
| +2 | K241468 | Vertiwedge® Intraosseous System | Foundation Surgical Group, Inc. | 2024 | — |
| +3 | K261810 | Vertiwedge® Intraosseous System | Foundation Surgical Group | 2026 | — |
| +1 | K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K133194 | Diamond Rattlesnake SystemSummary page 6…Trade or Proprietary or Model Name Manufacturer Type Number Black/Red Diamond Rattlesnake Lumbar Plating K133194 Eminent Spine Primary Syste… | 2014 |
| * | K070922 | Modification to Spinal Usa VBR SystemSummary page 6…ttlesnake Lumbar Plating K133194 Eminent Spine Primary System K070922 Anterior Lumbar Plate System Spinal USA Additional K020244 Thoracolumbar Spine Loc… | 2007 |
| * | K020244 | Synthes Thoracolumbar Spine Locking Plate (TSLP)Summary page 6…ent Spine Primary System K070922 Anterior Lumbar Plate System Spinal USA Additional K020244 Thoracolumbar Spine Locking Plate (TSLP) System Synthes Additional TECHNOLOGICAL CHARACTERISTICS The follow… | 2002 |
What descends from it? (4)
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 23 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K220324 (Precision Spine, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K133194.
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. 2016, 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 AccuFit Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative…
Read the full statement (112 words)
The AccuFit Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels 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), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162211: AccuFit Lateral Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162211
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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