510(k) · Cleared
Recalled · Class II · 2018Excella II Spinal System Model EC2-00
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasis, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 7, 2010 as substantially equivalent to K071921 (Innovasis, Inc., 2007) after a 59-day review. Its family tree reaches back 5 generations to 1990. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 7, 2010
- Review
- 59 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 5 generations to K901587 (1990). 33 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 4 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 3 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 2 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 1 generation backK071921 Innovasis Excella Spinal System, Excella-M (Monoaxial Screws)…Innovasis, Inc. · 2007
- This deviceK102248 Excella II Spinal System Model EC2-00Innovasis, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK140238 Excella Iii-D Spinal Deformity SystemInnovasis, Inc. · 2014 · Recalled
- Descendant · cites it directly · 1 of its ownK241276 Vector™ Pedicle Screw SystemInnovasis, Inc. · 2024 · Recalled
- Descendant · cites it directly · 0 of its ownK251073 Innovasis Navigation Instruments (Vector G-E Navigation Instruments…Innovasis, Inc. · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK162143 FixxSure® X-LinkInnovasis, Inc. · 2016
Most influential descendants
Showing 4 of 4 · See all- K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc. · 2014 · cites it directly3descendants
- K241276Vector™ Pedicle Screw SystemInnovasis, Inc. · 2024 · cites it directly1descendant
- K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc. · 2025 · cites it directly0descendants
- K162143FixxSure® X-LinkInnovasis, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −4 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −3 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −2 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −1 | K071921 | Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P… | Innovasis, Inc. | 2007 | — |
| 0 (this device) | K102248 | Excella II Spinal System Model EC2-00 | Innovasis, Inc. | 2010 | — |
| +1 | K140238 | Excella Iii-D Spinal Deformity System | Innovasis, Inc. | 2014 | 2 |
| +1 | K241276 | Vector™ Pedicle Screw System | Innovasis, Inc. | 2024 | 1 |
| +1 | K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the… | Innovasis, Inc. | 2025 | 1 |
| +2 | K162143 | FixxSure® X-Link | Innovasis, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K071921 | Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Summary page 1…Fixation of the Spinal Skeletal System Substantially Equivalent Device: K071921 Excella® Spinal System Qevice Description: The Excella IITM Spinal System consists of 6AL-4V… | 2007 |
What descends from it? (4)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 8, 2018 | Class II | Z-0644-2018 | Nonconforming Material/Component | Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage. |
| Dec 7, 2015 | Class II | Z-0662-2016 | Labeling mix-ups | Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels. |
| Jul 7, 2014 | Class II | Z-2067-2014 | Process control | Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 33 ancestors has a recall.
- Of its descendants, K140238 (Innovasis, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K071921.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Innovasis® Excella® Spinal System is intended for use in the non-cervical area of the spine. The INNOVASIS® Excella® 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 and sacral spine (L3 and below); and d) Who are having the…
Read the full statement (297 words)
The Innovasis® Excella® Spinal System is intended for use in the non-cervical area of the spine.
The INNOVASIS® Excella® 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 and sacral spine (L3 and below); and d) Who are having the device removed after the development of a solid fusion mass.
The INNOVASIS® Excella® 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:
i. Degenerative spondylolisthesis with objective evidence of neurologic impairment; ii. Fracture; iii. Dislocation; iv. Scoliosis; v. Kyphosis; vi. Spinal tumor; and vii. Previous failed fusion (pseudoarthrosis).
The INNOVASIS® Excella® Spinal System, when used for anterolateral non-pedicle fixation, is intended for the following indications:
i. Degenerative disc disease* ii. Spinal stenosis; iii. Spondylolisthesis; iv. Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis); v. Pseudoarthrosis vi. Tumor vii. Trauma (i.e. fracture or dislocation); and viii. Previous failed fusion.
*(defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
The INNOVASIS® Excella® Spinal System, when used for Posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
i. Degenerative disc disease; ii. Spinal stenosis; iii. Spondylolisthesis; iv. Spinal deformities (i.e. scoliosis, kyphosis and/or lordosis); v. Pseudoarthrosis vi. Tumor; vii. Trauma (i.e. fracture or dislocation); viii. Previous failed fusion.
*(defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102248: Excella II Spinal System Model EC2-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102248
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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