510(k) · Cleared
ClearedModification to Macs Modular Anterior Construct 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 Jul 25, 2003 as substantially equivalent to K002824 (Aesculap, Inc., 2001) and 3 other predicates after a 23-day review. Its family tree reaches back 3 generations to 1998. 250 later devices descend from it.
- Decided
- Jul 25, 2003
- Review
- 23 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K983583 (1998). 8 ancestors in all, the oldest K922543 (1993). 250 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK983583 Depuy Acromed Moss and Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 2 generations backK994347 Centaur Spinal SystemHowmedica Osteonics Corp. · 2000
- 1 generation backK002824 Macs Modular Anterior Construct SystemAesculap, Inc. · 2001
- This deviceK032059 Modification to Macs Modular Anterior Construct SystemAesculap, Inc. · 2003
- Descendant · cites it directly · 248 of its ownK070387 Expedium Spine SystemDepuy Spine, Inc. · 2007
- Descendant · 2 generations on · 218 of its ownK102249 Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company · 2010
- Descendant · 2 generations on · 203 of its ownK111571 Viper SystemsJohnson & Johnson · 2011
- Descendant · 3 generations on · 94 of its ownK121020 Viper SystemDepuy Spine, Inc. · 2012
- Descendant · 4 generations on · 84 of its ownK153442 CD HORIZON Spinal System, Medtronic Navigated Manual Reusable…Medtronic Sofamor Danek USA, Inc. · 2016
Showing 5 of 250 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 250 · See all- K070387Expedium Spine SystemDepuy Spine, Inc. · 2007 · cites it directly248descendants
- K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company · 2010 · 2 generations on218descendants
- K111571Viper SystemsJohnson & Johnson · 2011 · 2 generations on203descendants
- K121020Viper SystemDepuy Spine, Inc. · 2012 · 3 generations on94descendants
- K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc. · 2016 · 4 generations on84descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983583 | Depuy Acromed Moss and Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −2 | K994347 | Centaur Spinal System | Howmedica Osteonics Corp. | 2000 | — |
| −1 | K002824 | Macs Modular Anterior Construct System | Aesculap, Inc. | 2001 | — |
| 0 (this device) | K032059 | Modification to Macs Modular Anterior Construct System | Aesculap, Inc. | 2003 | — |
| +1 | K070387 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| +2 | K102249 | Expedium Spine System | Depuy Spine, A Johnson & Johnson Company | 2010 | — |
| +2 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| +3 | K121020 | Viper System | Depuy Spine, Inc. | 2012 | — |
| +4 | K153442 | CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for… | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 6 | 0 |
| 2013 | 12 | 0 |
| 2014 | 12 | 0 |
| 2015 | 13 | 0 |
| 2016 | 10 | 0 |
| 2017 | 8 | 0 |
| 2018 | 17 | 0 |
| 2019 | 13 | 0 |
| 2020 | 15 | 0 |
| 2021 | 11 | 0 |
| 2022 | 19 | 0 |
| 2023 | 29 | 0 |
| 2024 | 28 | 0 |
| 2025 | 28 | 0 |
| 2026 | 22 | 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? (4)
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 |
|---|---|---|---|
| * | K002824 | Macs Modular Anterior Construct SystemSummary page 2…CE Aesculap believes that the MACSTLModular Anterior Construct System Line Extension is substantially equivalent to the existing MACSTLModular Anterior Construct System (K002824) and the following other predicate devices: MACSTLHMA Anterior Spinal Stabilization System (KO11556) K… | 2001 |
| * | K011556 | Macs Hma Anterior Spinal Stabilization System | 2001 |
| * | K990959 | K-Centrum Anterior Spinal Fixation SystemSummary page 2…and the following other predicate devices: MACSTLHMA Anterior Spinal Stabilization System (KO11556) K-Centrum Anterior Spinal Fixation System (K990959 & K002371) DEPARTMENT OF HEACTH & HUMAN SERVICES Public Health Servi… | 1999 |
| * | K002371 | K-Centrum Anterior Spinal Fixation SystemSummary page 2…llowing other predicate devices: MACSTLHMA Anterior Spinal Stabilization System (KO11556) K-Centrum Anterior Spinal Fixation System (K990959 & K002371) DEPARTMENT OF HEACTH & HUMAN SERVICES Public Health Service… | 2000 |
What descends from it? (250)
See all 2502 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 5 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K070387 (Depuy Spine, Inc., 2007) has gone furthest, with 248 descendants of its own.
- 2 other devices also cite its predicate K002824.
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 (TI-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 Modular Anterior Construct System is indicated…
Read the full statement (120 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 (TI-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 Modular Anterior Construct 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
Revision of previous surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032059: Modification to Macs Modular Anterior Construct System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032059
Report an extraction error
Are you the manufacturer?
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