510(k) · Cleared
ClearedNILE Alternative 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 Mar 18, 2016 as substantially equivalent to K143350 (K2m, Inc., 2015) and 2 other predicates after a 50-day review. Its family tree reaches back 18 generations to 1985. 1 of the 388 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Mar 18, 2016
- Review
- 50 days
- Class
- Class II
- Product code
- OWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K853033 (1985). 382 ancestors in all, the oldest K781443 (1978). 5 later devices descend from it, 1 citing it directly. 1 of the 388 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 14 generations between
- 3 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
- 2 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- 1 generation backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- This deviceK160208 NILE Alternative Fixation Spinal SystemK2m, Inc. · 2016
- 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 18 generations
- Root · 18 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 17 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 16 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 15 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 14 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 13 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 12 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 11 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 10 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 9 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 8 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 7 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 6 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 5 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 4 generations backK130330 Range Spinal SystemK2m, Inc. · 2013
- 3 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
- 2 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- 1 generation backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- This deviceK160208 NILE Alternative Fixation Spinal SystemK2m, Inc. · 2016
Class I recalls in this family
- K073202 Ardis Spacer3 generations back · 2008
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 |
|---|---|---|---|---|---|
| −18 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −17 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −16 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −15 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −14 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −13 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −12 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −11 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −10 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −9 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −8 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −7 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −6 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −5 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| −4 | K130330 | Range Spinal System | K2m, Inc. | 2013 | — |
| −3 | K131784 | Range Spinal System | K2m, Inc. | 2013 | — |
| −2 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| −1 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| 0 (this device) | K160208 | NILE Alternative Fixation Spinal System | K2m, Inc. | 2016 | — |
| +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 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 11 | 0 |
| 1999 | 12 | 0 |
| 2000 | 18 | 0 |
| 2001 | 28 | 0 |
| 2002 | 20 | 0 |
| 2003 | 27 | 0 |
| 2004 | 43 | 0 |
| 2005 | 33 | 0 |
| 2006 | 19 | 0 |
| 2007 | 19 | 0 |
| 2008 | 31 | 1 |
| 2009 | 19 | 0 |
| 2010 | 12 | 0 |
| 2011 | 21 | 0 |
| 2012 | 13 | 0 |
| 2013 | 8 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 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.
1 device in this family has a Class I recall. 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? (3)
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) Secondary Predicates: K2M Range/ Denali/ Mesa Spinal System (K141873) K2M Cascadia Interbody System (K150481) Device Descriptio… | 2015 |
| * | K141873 | Range/Mesa/Denali Spinal SystemSummary page 4…uct Code OWI) Predicate Device(s) Primary Predicate: K2M NILE Alternative Fixation Spinal System (K143350) Secondary Predicates: K2M Range/ Denali/ Mesa Spinal System (K141873) K2M Cascadia Interbody System (K150481) Device Description The NILE Alternative Fixation Spinal System implants are comprised o… | 2014 |
| * | K150481 | Cascadia Interbody SystemSummary page 4…ary Predicate: K2M NILE Alternative Fixation Spinal System (K143350) Secondary Predicates: K2M Range/ Denali/ Mesa Spinal System (K141873) K2M Cascadia Interbody System (K150481) Device Description The NILE Alternative Fixation Spinal System implants are comprised of bands, clamps and set screws designed… | 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? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 38 of the 382 ancestors have a recall of any class; 1 has a Class I recall.
- 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. 2016, 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 Spinal System is a temporary implant for use in orthopedic surgery. The system is 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…
Read the full statement (136 words)
The NILE Alternative Fixation Spinal System is a temporary implant for use in orthopedic surgery. The system is 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 Spinal System 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/K160208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160208: NILE Alternative 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/K160208
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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