510(k) · Cleared
Recalled · Class II · 2017Polyscrew Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Era Orthopedics, LLC · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Apr 8, 2015 as substantially equivalent to K141253 (New Era Orthopaedics, LLC, 2015) and 1 other predicate after a 27-day review. Its family tree reaches back 16 generations to 1985. 1 of the 249 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Apr 8, 2015
- Review
- 27 days
- Class
- Class II
- Product code
- MNI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 16 generations to K853033 (1985). 248 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 249 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 12 generations between
- 3 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 2 generations backK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- 1 generation backK141253 New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC · 2015 · Recalled
- This deviceK150647 Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC · 2015
Show all 16 generations
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 15 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 14 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 13 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 12 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 11 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 10 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 9 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 8 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 7 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 6 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 5 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 4 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 3 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 2 generations backK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- 1 generation backK141253 New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC · 2015 · Recalled
- This deviceK150647 Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC · 2015
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −15 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −14 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −13 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −12 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −11 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −10 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −9 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −8 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −7 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −6 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −5 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −4 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −3 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| −2 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| −1 | K141253 | New Era Orthopaedics Polyscrew Pedicle Screw System | New Era Orthopaedics, LLC | 2015 | 1 |
| 0 (this device) | K150647 | Polyscrew Pedicle Screw System | New Era Orthopedics, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 7 | 0 |
| 1998 | 11 | 0 |
| 1999 | 11 | 0 |
| 2000 | 15 | 0 |
| 2001 | 19 | 0 |
| 2002 | 12 | 0 |
| 2003 | 13 | 0 |
| 2004 | 25 | 0 |
| 2005 | 22 | 0 |
| 2006 | 12 | 0 |
| 2007 | 11 | 0 |
| 2008 | 11 | 0 |
| 2009 | 11 | 0 |
| 2010 | 10 | 1 |
| 2011 | 8 | 0 |
| 2012 | 3 | 0 |
| 2013 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K141253 | New Era Orthopaedics Polyscrew Pedicle Screw SystemSummary page 5…TEM The purpose of this submission is to update the Surgical Technique to include in-situ assembly of the New Era Orthopaedics™ Polyscrew Pedicle Screw System cleared in K141253. INDICATIONS FOR USE The New Era Orthopaedics Polyscrew Pedicle Screw System is intended to provide immobilization and stabiliza… | 2015 |
| * | K124058 | Creo Stabilization SystemSummary page 6…Manufacturer Type Name K141253 Polyscrew Pedicle Screw System New Era Orthopaedics Primary K124058 CREO™ Stabilization System Globus Medical Inc. Additional SUMMARY OF PERFORMANCE TESTING Per… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 13, 2017 | Class II | Z-2604-2018 | Device Design | This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Screw system implants. The firm received a customer complaint in which excessive forces were applied to the shank insertion… |
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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 25 of the 248 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The New Era Orthopaedics Polyscrew Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis…
Read the full statement (163 words)
The New Era Orthopaedics Polyscrew Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.
The New Era Orthopaedics Polyscrew Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150647: Polyscrew Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150647
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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