510(k) Report

510(k) · Cleared

Cleared

Pass Spinal System

K001024510(k) TraditionalCleared May 23, 200054-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Encore Orthopedics, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on May 23, 2000 after a 54-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 155 later devices descend from it.

Decided
May 23, 2000
Review
54 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
0

155 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2001: 3 descendants cleared2003: 1 descendant cleared2006: 1 descendant cleared2007: 2 descendants cleared2011: 2 descendants cleared2013: 4 descendants cleared2019: 3 descendants cleared2016: 7 descendants cleared2015: 5 descendants cleared2022: 13 descendants cleared2014: 1 descendant cleared2017: 8 descendants cleared2018: 8 descendants cleared2020: 6 descendants cleared2023: 15 descendants cleared2026: 25 descendants cleared2021: 6 descendants cleared2024: 19 descendants cleared2025: 24 descendants cleared200020052010201520202025
  1. This deviceK001024 Pass Spinal SystemEncore Orthopedics, Inc. · 2000
  2. Descendant · cites it directly · 150 of its ownK020236 Modification to Pass Spinal SystemEncore Orthopedics, Inc. · 2002
  3. Descendant · cites it directly · 150 of its ownK013442 Pass Spinal SystemEncore Orthopedics, Inc. · 2002
  4. Descendant · cites it directly · 150 of its ownK013431 Pass Spinal SystemEncore Orthopedics, Inc. · 2001
  5. Descendant · cites it directly · 150 of its ownK013191 Pass Spinal SystemEncore Orthopedics, Inc. · 2001
  6. Descendant · cites it directly · 150 of its ownK012175 Pass Spinal SystemEncore Orthopedics, Inc. · 2001

Showing 5 of 155 descendants. See all descendants

Descendants cleared per year

2001: 32002: 22003: 12006: 12007: 22011: 22013: 42014: 12015: 52016: 72017: 82018: 82019: 32020: 62021: 62022: 132023: 152024: 192025: 242026: 25
2001high 25 (2026) · low 0 (2004)2026

Most influential descendants

Showing 5 of 155 · See all
  • K020236Modification to Pass Spinal SystemEncore Orthopedics, Inc. · 2002 · cites it directly150descendants
  • K013442Pass Spinal SystemEncore Orthopedics, Inc. · 2002 · cites it directly150descendants
  • K013431Pass Spinal SystemEncore Orthopedics, Inc. · 2001 · cites it directly150descendants
  • K013191Pass Spinal SystemEncore Orthopedics, Inc. · 2001 · cites it directly150descendants
  • K012175Pass Spinal SystemEncore Orthopedics, Inc. · 2001 · cites it directly150descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001024Pass Spinal SystemEncore Orthopedics, Inc.2000—
+1K020236Modification to Pass Spinal SystemEncore Orthopedics, Inc.2002—
+1K013442Pass Spinal SystemEncore Orthopedics, Inc.2002—
+1K013431Pass Spinal SystemEncore Orthopedics, Inc.2001—
+1K013191Pass Spinal SystemEncore Orthopedics, Inc.2001—
+1K012175Pass Spinal SystemEncore Orthopedics, Inc.2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200130
200220
200310
200610
200720
201120
201340
201410
201550
201670
201780
201880
201930
202060
202160
2022130
2023150
2024190
2025240
2026250
FIG. 1 — Lineage of K001024, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (155)

See all 155

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020236Modification to Pass Spinal SystemEncore Orthopedics, Inc.2002150
K013442Pass Spinal SystemEncore Orthopedics, Inc.2002150
K013431Pass Spinal SystemEncore Orthopedics, Inc.2001150
K013191Pass Spinal SystemEncore Orthopedics, Inc.2001150
K012175Pass Spinal SystemEncore Orthopedics, Inc.2001150
K032094Passmed Spinal SystemMedicrea2003149

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?

  • Of its descendants, K020236 (Encore Orthopedics, Inc., 2002) has gone furthest, with 150 descendants of its own.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

More from Encore Orthopedics, Inc.

85 FDA decisions under this applicant name. See the company

  • K0329053DKNEE Porous Coated Femoral ComponentEncore Orthopedics, Inc. · 2004
  • K0201143D KNEEEncore Orthopedics, Inc. · 20025 recalls
  • K020741Unicondylar KneeEncore Orthopedics, Inc. · 20022 recalls
  • K020236Modification to Pass Spinal SystemEncore Orthopedics, Inc. · 2002
  • K020170Keystone Hip System Calcar Replacement Body and Build UPEncore Orthopedics, Inc. · 2002

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K001024 · printed Nov 3, 2026

Cite this page

510(k) Report. “K001024: Pass Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K001024

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026