510(k) · Cleared
ClearedMacs Hma Anterior Spinal Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Nov 16, 2001 as substantially equivalent to K990959 (Spineology, Inc., 1999) and 1 other predicate after a 179-day review. Its family tree reaches back 2 generations to 1993. 293 later devices descend from it.
- Decided
- Nov 16, 2001
- Review
- 179 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K922543 (1993). 3 ancestors in all. 293 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK922543 Z-Plate Anterior Fixation SystemSofamor Danek Mfg., Inc. · 1993
- 1 generation backK990959 K-Centrum Anterior Spinal Fixation SystemSpineology, Inc. · 1999
- This deviceK011556 Macs Hma Anterior Spinal Stabilization SystemAesculap, Inc. · 2001
- Descendant · cites it directly · 250 of its ownK032059 Modification to Macs Modular Anterior Construct SystemAesculap, Inc. · 2003
- Descendant · 2 generations on · 248 of its ownK070387 Expedium Spine SystemDepuy Spine, Inc. · 2007
- Descendant · 3 generations on · 218 of its ownK102249 Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company · 2010
- Descendant · 3 generations on · 203 of its ownK111571 Viper SystemsJohnson & Johnson · 2011
- Descendant · 4 generations on · 94 of its ownK121020 Viper SystemDepuy Spine, Inc. · 2012
Showing 5 of 293 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 293 · See all- K032059Modification to Macs Modular Anterior Construct SystemAesculap, Inc. · 2003 · cites it directly250descendants
- K070387Expedium Spine SystemDepuy Spine, Inc. · 2007 · 2 generations on248descendants
- K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company · 2010 · 3 generations on218descendants
- K111571Viper SystemsJohnson & Johnson · 2011 · 3 generations on203descendants
- K121020Viper SystemDepuy Spine, Inc. · 2012 · 4 generations on94descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922543 | Z-Plate Anterior Fixation System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −1 | K990959 | K-Centrum Anterior Spinal Fixation System | Spineology, Inc. | 1999 | — |
| 0 (this device) | K011556 | Macs Hma Anterior Spinal Stabilization System | Aesculap, Inc. | 2001 | — |
| +1 | K032059 | Modification to Macs Modular Anterior Construct System | Aesculap, Inc. | 2003 | — |
| +2 | K070387 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| +3 | K102249 | Expedium Spine System | Depuy Spine, A Johnson & Johnson Company | 2010 | — |
| +3 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| +4 | K121020 | Viper System | Depuy Spine, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 13 | 0 |
| 2014 | 12 | 0 |
| 2015 | 13 | 0 |
| 2016 | 10 | 0 |
| 2017 | 8 | 0 |
| 2018 | 17 | 0 |
| 2019 | 13 | 0 |
| 2020 | 15 | 0 |
| 2021 | 12 | 0 |
| 2022 | 24 | 0 |
| 2023 | 36 | 0 |
| 2024 | 36 | 0 |
| 2025 | 38 | 0 |
| 2026 | 31 | 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? (2)
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 |
|---|---|---|---|
| * | K990959 | K-Centrum Anterior Spinal Fixation SystemSummary page 2…t in their intended use, design, and basic operating principles to the following predicate devices: e K-Centrum Anterior Spinal Fixation System By The Spineology Group (#K990959 & K002371) The K-Centrum® - Anterior Spinal Fixation System is cleared for marketing. K-Centrum® is an anterior spinal construct… | 1999 |
| * | K002371 | K-Centrum Anterior Spinal Fixation SystemSummary page 2…intended use, design, and basic operating principles to the following predicate devices: e K-Centrum Anterior Spinal Fixation System By The Spineology Group (#K990959 & K002371) The K-Centrum® - Anterior Spinal Fixation System is cleared for marketing. K-Centrum® is an anterior spinal construct made up of… | 2000 |
| † | K002824 | Macs Modular Anterior Construct System | 2001 |
What descends from it? (293)
See all 2933 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 8 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K032059 (Aesculap, Inc., 2003) has gone furthest, with 250 descendants of its own.
- 1 other device also cites its predicate K990959.
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.
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 anterolateral / anterior system consists of several vertebral screws, locking nuts, spine plates and rods. The points of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T3-L5). This system is intended to provide stabilization during the development of a solid spinal fusion. When used as an anterolateral / anterior spine plate and rod system, the macs'™ HMA Anterior Spinal Stabilization System is…
Read the full statement (121 words)
This anterolateral / anterior system consists of several vertebral screws, locking nuts, spine plates and rods. The points of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T3-L5). This system is intended to provide stabilization during the development of a solid spinal fusion. When used as an anterolateral / anterior spine plate and rod system, the macs'™ HMA Anterior Spinal Stabilization System is indicated for patients with:
Degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
Spondylolisthesis
Spondylolysis
Fracture
Spinal stenosis
Deformities (i.e., scoliosis, kyphosis, lordosis, whether neuromuscular or related to deficient posterior elements)
Tumors (neoplastic disease)
Pseudarthrosis
Failed previous fusion surgery
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/K011556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011556: Macs Hma Anterior Spinal Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011556
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026