510(k) · Cleared
ClearedNILE Proximal Fixation Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2m, Inc. · OWI Bone Fixation Cerclage, Sublaminar
Cleared on Apr 5, 2017 as substantially equivalent to K143350 (K2m, Inc., 2015) after a 328-day review. Its family tree reaches back 9 generations to 1995. 5 later devices descend from it.
- Decided
- Apr 5, 2017
- Review
- 328 days
- Class
- Class II
- Product code
- OWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K950697 (1995). 77 ancestors in all, the oldest K781443 (1978). 5 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 5 generations between
- 3 generations backK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
- 2 generations backK120099 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 1 generation backK143350 Nile Alternative FixationK2m, Inc. · 2015
- This deviceK161332 NILE Proximal Fixation Spinal SystemK2m, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK222684 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal…Stryker Spine · 2023
- Descendant · 2 generations on · 1 of its ownK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024
- Descendant · 2 generations on · 1 of its ownK240872 Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance · 2024
- Descendant · 3 generations on · 0 of its ownK253545 Vulcan Spinal SystemK2m, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK241863 Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance · 2024
Show all 9 generations
- Root · 9 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 8 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 7 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 6 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 5 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 4 generations backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- 3 generations backK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
- 2 generations backK120099 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 1 generation backK143350 Nile Alternative FixationK2m, Inc. · 2015
- This deviceK161332 NILE Proximal Fixation Spinal SystemK2m, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine · 2023 · cites it directly4descendants
- K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine · 2024 · 2 generations on1descendant
- K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance · 2024 · 2 generations on1descendant
- K253545Vulcan Spinal SystemK2m, Inc. · 2026 · 3 generations on0descendants
- K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −8 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −7 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −6 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −5 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −4 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −3 | K090230 | Expedium Spine System | Depuy Spine, Inc. | 2009 | — |
| −2 | K120099 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| −1 | K143350 | Nile Alternative Fixation | K2m, Inc. | 2015 | — |
| 0 (this device) | K161332 | NILE Proximal Fixation Spinal System | K2m, Inc. | 2017 | — |
| +1 | K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System… | Stryker Spine | 2023 | — |
| +2 | K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal… | Stryker Spine | 2024 | — |
| +2 | K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System | Clariance | 2024 | — |
| +3 | K253545 | Vulcan Spinal System | K2m, Inc. | 2026 | — |
| +3 | K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MIS | Clariance | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 3 | 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 OWI? 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 OWI device
- #1 K253615 Invictus Bands Systemscore 20.7 · 33 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 |
|---|---|---|---|
| * | K143350 | Nile Alternative FixationSummary page 4…Classification Name(s): Bone Fixation Cerclage (21 CFR 888.3010, Product Code OWI) Predicate Device(s) Primary Predicate: K2M NILE Alternative Fixation Spinal System (K143350) Reference Devices: K2M Range/ Denali/ Mesa Spinal System (K153031) K2M Everest Spinal System (K151727) Device Description The N… | 2015 |
| † | K153031 | RANGE/DENALI/MESA Spinal System | 2015 |
| † | K151727 | Everest Spinal System | 2015 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222684 | XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®… | 2023 | 4 |
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 22 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 77 ancestors have a recall of any class.
- Of its descendants, K222684 (Stryker Spine, 2023) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K143350.
How does its category compare?
All OWI devicesOWI Bone Fixation Cerclage, Sublaminar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OWI
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OWI
60in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWI
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWI
6in 2025
MAUDE reports naming product code OWI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 92 | 0 | 1 |
| 2015 | 3 | 93 | 0 | 1 |
| 2016 | 5 | 98 | 0 | 6 |
| 2017 | 7 | 77 | 0 | 6 |
| 2018 | 4 | 156 | 0 | 2 |
| 2019 | 3 | 51 | 0 | 13 |
| 2020 | 3 | 60 | 1 | 8 |
| 2021 | 1 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The NILE Alternative Fixation and NILE Proximal Fixation Spinal Systems are temporary implants for use in orthopedic surgery. The systems are intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: 1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; 2. Spinal…
Read the full statement (143 words)
The NILE Alternative Fixation and NILE Proximal Fixation Spinal Systems are temporary implants for use in orthopedic surgery. The systems are intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
3. Spinal degenerative surgery, as an adjunct to spinal fusions.
The NILE Alternative Fixation and NILE Proximal Fixation Spinal Systems may also be used in conjunction with other medical implants made of similar metals whenever 'wiring' may help secure the attachment of other implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161332: NILE Proximal Fixation Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161332
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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