510(k) · Cleared
ClearedHILINE™ Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · OWI Bone Fixation Cerclage, Sublaminar
Cleared on Apr 20, 2023 as substantially equivalent to K133482 (Globus Medical, Inc., 2014) and 4 other predicates after a 50-day review. Its family tree reaches back 16 generations to 2004.
- Decided
- Apr 20, 2023
- Review
- 50 days
- Class
- Class II
- Product code
- OWI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K040583 (2004). 181 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations between
- 3 generations backK132303 Implanet Spine SystemImplanet, S.A. · 2013
- 2 generations backK143731 IMPLANET Spine System (ISS)Implanet, S.A. · 2015
- 1 generation backK182771 ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A. · 2019
- This deviceK230565 HILINE™ Fixation SystemGlobus Medical, Inc. · 2023
Show all 16 generations
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 13 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 11 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 10 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 8 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 7 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 6 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 5 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 4 generations backK120564 Calypso SystemHogan Lovells US LLP · 2012
- 3 generations backK132303 Implanet Spine SystemImplanet, S.A. · 2013
- 2 generations backK143731 IMPLANET Spine System (ISS)Implanet, S.A. · 2015
- 1 generation backK182771 ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A. · 2019
- This deviceK230565 HILINE™ Fixation SystemGlobus Medical, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −13 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −11 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −10 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −8 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −7 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −6 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −5 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −4 | K120564 | Calypso System | Hogan Lovells US LLP | 2012 | — |
| −3 | K132303 | Implanet Spine System | Implanet, S.A. | 2013 | — |
| −2 | K143731 | IMPLANET Spine System (ISS) | Implanet, S.A. | 2015 | — |
| −1 | K182771 | ISS-JAZZ Screw System and JAZZ CAP SP | Implanet, S.A. | 2019 | — |
| 0 (this device) | K230565 | HILINE™ Fixation System | Globus Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 10 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 13 | 0 |
| 2004 | 18 | 0 |
| 2005 | 17 | 0 |
| 2006 | 13 | 0 |
| 2007 | 7 | 0 |
| 2008 | 13 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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? (5)
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 |
|---|---|---|---|
| * | K133482 | Silc Fixation SystemSummary page 4…Bone Fixation Cerclage Product Code: OWI Regulatory Class: II, Panel Code: 87 Primary Predicate: SILC® Fixation System (K133482) Additional Predicates: SILC® Fixation System (K172417) Implanet JAZZ™ LOCK (K153348)… | 2014 |
| * | K172417 | SILC® Fixation SystemSummary page 4…Regulatory Class: II, Panel Code: 87 Primary Predicate: SILC® Fixation System (K133482) Additional Predicates: SILC® Fixation System (K172417) Implanet JAZZ™ LOCK (K153348) Implanet JAZZ™ CAP SP (K182771) Medicr… | 2017 |
| * | K153348 | Jazz LockSummary page 4…87 Primary Predicate: SILC® Fixation System (K133482) Additional Predicates: SILC® Fixation System (K172417) Implanet JAZZ™ LOCK (K153348) Implanet JAZZ™ CAP SP (K182771) Medicrea LigaPASS™ 2.0 (K213659) Reference Device:… | 2016 |
| * | K182771 | ISS-JAZZ Screw System and JAZZ CAP SPSummary page 4…em (K133482) Additional Predicates: SILC® Fixation System (K172417) Implanet JAZZ™ LOCK (K153348) Implanet JAZZ™ CAP SP (K182771) Medicrea LigaPASS™ 2.0 (K213659) Reference Device: CREO™ Stabilization System (K124058, K180210… | 2019 |
| * | K213659 | LigaPASS™ 2.0 Ligament Augmentation SystemSummary page 4…xation System (K172417) Implanet JAZZ™ LOCK (K153348) Implanet JAZZ™ CAP SP (K182771) Medicrea LigaPASS™ 2.0 (K213659) Reference Device: CREO™ Stabilization System (K124058, K180210) Purpose: The purpose of this submission is to requ… | 2022 |
| † | K124058 | Creo Stabilization System | 2013 |
| † | K180210 | CREO® Stabilization System | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 6 companies; a new generation was cleared every 8 months on median.
- 19 of the 181 ancestors have a recall of any class.
- 2 other devices also cite its predicate K133482.
How does its category compare?
All OWI devicesOWI Bone Fixation Cerclage, Sublaminar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 HILINE™ Fixation System consists of temporary implants 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: Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; Spinal reconstructive surgery, incorporated into constructs for…
Read the full statement (141 words)
The HILINE™ Fixation System consists of temporary implants 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:
Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;
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;
Spinal degenerative surgery, as an adjunct to spinal fusions;
Use with a posterior spinal instrumentation construct when ligament augmentation is needed.
The HILINE™ Fixation 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K230565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230565: HILINE™ Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230565
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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