510(k) · Cleared
ClearedPerfix Iliac Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U&I Corporation · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Dec 17, 2013 as substantially equivalent to K011437 (Interpore Cross Intl., 2001) and 2 other predicates after a 153-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Dec 17, 2013
- Review
- 153 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K000319 (2000). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 2 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 1 generation backK024096 Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- This deviceK132218 Perfix Iliac Screw SystemU&I Corporation · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −2 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −1 | K024096 | Optima, Spinal System | U&I Corp., America | 2003 | 3 |
| 0 (this device) | K132218 | Perfix Iliac Screw System | U&I Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K011437 | Synergy 4.0 MM, 4.5 MM VLS ScrewsSummary page 1…mon Name: Spinal Fixation System Product Code: MNH, MNI, KWP Predicate Devices: Synergy TM Spinal System - Synergy VLS Screws (K011437) OPTIMATM Spinal System (K024096) Global Spinal Fixation System TM (K00… | 2001 |
| * | K024096 | Optima, Spinal SystemSummary page 1…: MNH, MNI, KWP Predicate Devices: Synergy TM Spinal System - Synergy VLS Screws (K011437) OPTIMATM Spinal System (K024096) Global Spinal Fixation System TM (K001668) PerfixTMIliac Screw System… | 2003 |
| * | K001668 | Global Spinal Fixation SystemSummary page 1…Spinal System - Synergy VLS Screws (K011437) OPTIMATM Spinal System (K024096) Global Spinal Fixation System TM (K001668) PerfixTMIliac Screw System W OPRTO… | 2000 |
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 13 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 11 other devices also cite its predicate K011437.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Perfix™ Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine: * Spondylolisthesis (Grade 3 and 4) * Degenerative spondylolisthesis with objective evidence of neurological…
Read the full statement (130 words)
The Perfix™ Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
* Spondylolisthesis (Grade 3 and 4)
* Degenerative spondylolisthesis with objective evidence of neurological impairment
* Trauma (i.e., fracture or dislocation)
* Spinal stenosis
* Spinal deformities (Scoliosis, Kyphosis, Lordosis)
* Pelvic obliquity
* Spinal tumor
* Pseudarthrosis
* Failed previous fusion
The Perfix™ Iliac Screw System includes the following four components; iliac screw, iliac connector, iliac cap, and a set screw. These components are only to be used in conjunction with the Perfix™ Spinal System's 6.0mm diameter rods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132218 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132218: Perfix Iliac 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/K132218
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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