510(k) · Cleared
ClearedExactech Proliant Polyaxial Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jan 21, 2011 as substantially equivalent to K051216 (Altiva Corp., 2005) and 2 other predicates after a 113-day review. Its family tree reaches back 10 generations to 1990. 9 later devices descend from it.
- Decided
- Jan 21, 2011
- Review
- 113 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K901587 (1990). 57 ancestors in all. 9 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 6 generations between
- 3 generations backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- 2 generations backK062670 Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated · 2007
- 1 generation backK073245 Extended Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008
- This deviceK102870 Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK151704 Diplomat® Spinal SystemSignus Medizintechnik GmbH · 2016
- Descendant · 2 generations on · 2 of its ownK191932 Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 2019
- Descendant · 3 generations on · 1 of its ownK231809 Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone…Ulrich Medical USA · 2023
- Descendant · cites it directly · 1 of its ownK141282 PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group · 2014
- Descendant · 3 generations on · 0 of its ownK251719 Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 9 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 8 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 7 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 6 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- 5 generations backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- 4 generations backK032739 Ucr Spinal SystemSeaspine · 2003
- 3 generations backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- 2 generations backK062670 Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated · 2007
- 1 generation backK073245 Extended Vertiflex Spinal Screw SystemVertiflex, Inc. · 2008
- This deviceK102870 Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc. · 2011
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH · 2016 · cites it directly4descendants
- K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA · 2019 · 2 generations on2descendants
- K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA · 2023 · 3 generations on1descendant
- K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group · 2014 · cites it directly1descendant
- K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −9 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −8 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −7 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −6 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| −5 | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| −4 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| −3 | K043232 | Ucr Spinal System | Seaspine | 2004 | 1 |
| −2 | K062670 | Vertiflex Spinal Screw System | Vertiflex (Tm), Incorporated | 2007 | — |
| −1 | K073245 | Extended Vertiflex Spinal Screw System | Vertiflex, Inc. | 2008 | — |
| 0 (this device) | K102870 | Exactech Proliant Polyaxial Pedicle Screw System | Exactech, Inc. | 2011 | — |
| +1 | K151704 | Diplomat® Spinal System | Signus Medizintechnik GmbH | 2016 | — |
| +2 | K191932 | Momentum™ Posterior Spinal Fixation System | Ulrich Medical USA | 2019 | — |
| +3 | K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement… | Ulrich Medical USA | 2023 | — |
| +1 | K141282 | PGS 5.5 MM Cannulated Pedicle Screw | Pinnacle Spine Group | 2014 | — |
| +3 | K251719 | Momentum® Posterior Spinal Fixation System | Ulrich Medical USA, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 MNH? 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? (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 |
|---|---|---|---|
| * | K051216 | Hydralok SystemSummary page 1…n " Product Code: MNH - Orthosis, Spondylolisthiesis Spinal Fixation Legally Marketed Devices to Which Substantial Equivalence Is Claimed " Hydralok TM System (KO051216) " VSS System (K062670) and Extended VSS System (K073245) Device Description This submission proposes a new pedicle screw spi… | 2005 |
| * | K062670 | Vertiflex Spinal Screw SystemSummary page 1…- Orthosis, Spondylolisthiesis Spinal Fixation Legally Marketed Devices to Which Substantial Equivalence Is Claimed " Hydralok TM System (KO051216) " VSS System (K062670) and Extended VSS System (K073245) Device Description This submission proposes a new pedicle screw spinal Fixation system. The p… | 2007 |
| * | K073245 | Extended Vertiflex Spinal Screw SystemSummary page 1…nal Fixation Legally Marketed Devices to Which Substantial Equivalence Is Claimed " Hydralok TM System (KO051216) " VSS System (K062670) and Extended VSS System (K073245) Device Description This submission proposes a new pedicle screw spinal Fixation system. The proposed Proliant Polyaxial Pedicle… | 2008 |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 9 companies; a new generation was cleared every 2.1 years on median.
- 9 of the 57 ancestors have a recall of any class.
- Of its descendants, K151704 (Signus Medizintechnik GmbH, 2016) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K051216.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Exactech® Proliant Polyaxial Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion…
Read the full statement (126 words)
The Exactech® Proliant Polyaxial Pedicle Screw System is intended to provide
immobilization and stabilization of spinal segments as an adjunct to fusion in the
treatment of the following acute and chronic instabilities or deformities of the thoracic,
lumbar and sacral spine including degenerative spondylolisthesis with objective evidence
of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and
failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the Proliant System is intended
for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the LS-S1I
vertebra, who are receiving fusion by autogenous bone graft only having the device
attached to the lumbar and sacral spine (L3 and below), who are having the device
removed after the development of a solid fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102870 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102870: Exactech Proliant Polyaxial Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102870
Report an extraction error
Are you the manufacturer?
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