510(k) · Cleared
ClearedPremia Spine XL Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Premia Spine, Ltd. · OLO Orthopedic Stereotaxic Instrument
Cleared on Oct 8, 2019 as substantially equivalent to K153442 (Medtronic Sofamor Danek USA, Inc., 2016) after a 90-day review. Its family tree reaches back 15 generations to 1985.
- Decided
- Oct 8, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K853033 (1985). 249 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations between
- 3 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 2 generations backK121020 Viper SystemDepuy Spine, Inc. · 2012
- 1 generation backK153442 CD HORIZON Spinal System, Medtronic Navigated Manual Reusable…Medtronic Sofamor Danek USA, Inc. · 2016
- This deviceK191854 Premia Spine XL InstrumentsPremia Spine, Ltd. · 2019
Show all 15 generations
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 14 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 13 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 12 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 11 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 10 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 9 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 8 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 7 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 6 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 4 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 3 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 2 generations backK121020 Viper SystemDepuy Spine, Inc. · 2012
- 1 generation backK153442 CD HORIZON Spinal System, Medtronic Navigated Manual Reusable…Medtronic Sofamor Danek USA, Inc. · 2016
- This deviceK191854 Premia Spine XL InstrumentsPremia Spine, Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −14 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −13 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −12 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −11 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −10 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −9 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −8 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −7 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −6 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −4 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −3 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −2 | K121020 | Viper System | Depuy Spine, Inc. | 2012 | — |
| −1 | K153442 | CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for… | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| 0 (this device) | K191854 | Premia Spine XL Instruments | Premia Spine, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 10 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 11 | 0 |
| 1999 | 12 | 0 |
| 2000 | 13 | 0 |
| 2001 | 21 | 0 |
| 2002 | 13 | 0 |
| 2003 | 15 | 0 |
| 2004 | 29 | 0 |
| 2005 | 22 | 0 |
| 2006 | 13 | 0 |
| 2007 | 8 | 0 |
| 2008 | 11 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 6 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 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 OLO? 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 OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 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 |
|---|---|---|---|
| * | K153442 | CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Summary page 4…xic instrument Regulatory Class: II Product Code: OLO Product Code Name: Orthopedic Stereotaxic Instrument 3. Predicate and Reference Device Information Predicate: K153442, Medtronic Navigated Reusable Instruments for Use with the StealthStation® and IPC® Powerease™ Systems 4. Device Description… | 2016 |
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 34 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 27 of the 249 ancestors have a recall of any class.
- 12 other devices also cite its predicate K153442.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
Premia Spine XL Instruments are intended to be used during the preparation and placement of Premia Spine screws during surgery to assist the surgeon in precisely locating anatomical structure in either open or minimally invasive procedures. Premia Spine XL Instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and…
Read the full statement (121 words)
Premia Spine XL Instruments are intended to be used during the preparation and placement of Premia Spine screws during surgery to assist the surgeon in precisely locating anatomical structure in either open or minimally invasive procedures.
Premia Spine XL Instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
The XL Instruments are nonsterile instruments that can be used manually. These instruments are intended to be used with the Medtronic’s StealthStation Navigation System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191854: Premia Spine XL Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191854
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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