510(k) · Cleared
ClearedExcella-M Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasis, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Oct 7, 2004 as substantially equivalent to K994217 (Blackstone Medical, Inc., 2000) and 3 other predicates after a 59-day review. Its family tree reaches back 3 generations to 1996. 6 later devices descend from it.
- Decided
- Oct 7, 2004
- Review
- 59 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K955348 (1996). 10 ancestors in all, the oldest K933881 (1994). 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- 2 generations backK964024 Depuy Motech Titanium Moss Miami Spinal SystemDepuy, Inc. · 1997
- 1 generation backK992168 Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 1999
- This deviceK042143 Excella-M Spinal SystemInnovasis, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK071921 Innovasis Excella Spinal System, Excella-M (Monoaxial Screws)…Innovasis, Inc. · 2007
- Descendant · 2 generations on · 4 of its ownK102248 Excella II Spinal System Model EC2-00Innovasis, Inc. · 2010 · Recalled
- Descendant · cites it directly · 3 of its ownK140238 Excella Iii-D Spinal Deformity SystemInnovasis, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK241276 Vector™ Pedicle Screw SystemInnovasis, Inc. · 2024 · Recalled
- Descendant · 3 generations on · 0 of its ownK251073 Innovasis Navigation Instruments (Vector G-E Navigation Instruments…Innovasis, Inc. · 2025 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc. · 2007 · cites it directly5descendants
- K102248Excella II Spinal System Model EC2-00Innovasis, Inc. · 2010 · 2 generations on4descendants
- K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc. · 2014 · cites it directly3descendants
- K241276Vector™ Pedicle Screw SystemInnovasis, Inc. · 2024 · 2 generations on1descendant
- K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| −2 | K964024 | Depuy Motech Titanium Moss Miami Spinal System | Depuy, Inc. | 1997 | — |
| −1 | K992168 | Moss Miami 6.35MM Polyaxial Screw | Depuyacromed | 1999 | — |
| 0 (this device) | K042143 | Excella-M Spinal System | Innovasis, Inc. | 2004 | — |
| +1 | K071921 | Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P… | Innovasis, Inc. | 2007 | — |
| +2 | K102248 | Excella II Spinal System Model EC2-00 | Innovasis, Inc. | 2010 | 3 |
| +1 | K140238 | Excella Iii-D Spinal Deformity System | Innovasis, Inc. | 2014 | 2 |
| +2 | K241276 | Vector™ Pedicle Screw System | Innovasis, Inc. | 2024 | 1 |
| +3 | K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the… | Innovasis, Inc. | 2025 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 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 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K994217 | Blackstone Spinal Fixation SystemSummary page 1…1 CRF 888.3070) Device Product Code: KWQ, KWP, MNH, [MNI. The Panel code is 87. Substantially Equivalent Devices: Blackstone Spinal Fixation System (k994217) DePuy Acromed Moss Miami system (k992 168) Synthes Universal Spinal… | 2000 |
| * | K992168 | Moss Miami 6.35MM Polyaxial ScrewSummary page 1…Panel code is 87. Substantially Equivalent Devices: Blackstone Spinal Fixation System (k994217) DePuy Acromed Moss Miami system (k992 168) Synthes Universal Spinal System (k990745) Interpore Cross Synergy IQ… | 1999 |
| * | K990745 | Modification to Synthes Universal Spinal SystemSummary page 1…Spinal Fixation System (k994217) DePuy Acromed Moss Miami system (k992 168) Synthes Universal Spinal System (k990745) Interpore Cross Synergy IQ Spinal System (k012871) Device Description: The INNOVAS… | 1999 |
| * | K012871 | Synergy TI Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176…Summary page 1…s Miami system (k992 168) Synthes Universal Spinal System (k990745) Interpore Cross Synergy IQ Spinal System (k012871) Device Description: The INNOVASIS 'Excella-M' Spinal System is a 6-4 Titanium Alloy device comprised of a variet… | 2001 |
What descends from it? (6)
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 8 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K071921 (Innovasis, Inc., 2007) has gone furthest, with 5 descendants of its own.
- 9 other devices also cite its predicate K994217.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Innovasis 'Excella-M' Spinal System is intended for use in the non-cervical area of the spine. The Innovasis 'Excella-M' Spinal System, when used for pedicle screw fixation is intended only for patients: a) Having severe spondylolisthesis (Grade 3 & 4) at the L5-S1 joint; b) Who are receiving fusion using autogenous bone graft only; c) Who are having the device fixed or attached to the lumbar sacral spine (L3 and below); and d) Who are having the…
Read the full statement (299 words)
The Innovasis 'Excella-M' Spinal System is intended for use in the non-cervical area of the spine.
The Innovasis 'Excella-M' Spinal System, when used for pedicle screw fixation is intended only for patients:
a) Having severe spondylolisthesis (Grade 3 & 4) at the L5-S1 joint;
b) Who are receiving fusion using autogenous bone graft only;
c) Who are having the device fixed or attached to the lumbar sacral spine (L3 and below); and
d) Who are having the device removed after the development of a solid fusion mass.
The Innovasis 'Excella-M' Spinal System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:
a) Degenerative spondylolisthesis with objective evidence of neurologic impairment; b) Fracture; c) Dislocation; d) Scoliosis; e) Kyphosis; f) Spinal tumor; and g) Previous failed fusion (pseudarthrosis).
The Innovasis 'Excella-M' Spinal System, when used for anterolateral non-pedicle fixation, is intended for the following indications:
a) Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spinal stenosis; c) Spondylolisthesis; d) Spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis); e) Pseudarthrosis; f) Tumor; g) Trauma (i.e. fracture or dislocation); and h) Previous failed fusion.
The Innovasis 'Excella-M' Spinal System, when used for posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
a) Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spinal stenosis; c) Spondylolisthesis; d) Spinal deformities (i.e. scoliosis, kyphosis and/or lordosis); e) Pseudarthrosis; f) Tumor; g) Trauma (i.e. fracture or dislocation); and h) Previous failed fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042143 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042143: Excella-M Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042143
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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