510(k) · Cleared

Recalled · 2009

Modification to Blackstone Modular Pedicle Screw System

K042514510(k) SpecialCleared Oct 7, 200421-day reviewClass II21 CFR 888.3070Recalls 2

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

Blackstone Medical, Inc. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Oct 7, 2004 as substantially equivalent to K994217 (Blackstone Medical, Inc., 2000) and 4 other predicates after a 21-day review. Its family tree reaches back 4 generations to 1998. 1 later device descends from it. It has been recalled 2 times.

Decided: Oct 7, 2004
Review: 21 days
Class: Class II
Product code: MNI
Recalls: 2
Predicates: 5

Its longest line of descent runs back 4 generations to K980447 (1998). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK980447 Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc. · 1998
3 generations backK013558 Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc. · 2002
2 generations backK022399 Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc. · 2002
1 generation backK030581 Blackstone Spinal Fixation System Lateral Offset (System Modification)Blackstone Medical, Inc. · 2003
This deviceK042514 Modification to Blackstone Modular Pedicle Screw SystemBlackstone Medical, Inc. · 2004
Descendant · cites it directly · 0 of its ownK111448 Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc. · 2012

Most influential descendants

Showing 1 of 1 · See all

K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc. · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K980447	Depuy Motech Moss Miami Spinal System	DePuy Orthopaedics, Inc.	1998	—
−3	K013558	Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw	Blackstone Medical, Inc.	2002	—
−2	K022399	Blackstone Spinal Fixation System Spacer	Blackstone Medical, Inc.	2002	—
−1	K030581	Blackstone Spinal Fixation System Lateral Offset (System Modification)	Blackstone Medical, Inc.	2003	—
0 (this device)	K042514	Modification to Blackstone Modular Pedicle Screw System	Blackstone Medical, Inc.	2004	—
+1	K111448	Icon (TM) Modular Pedicle Screw System	Orthofix, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2000	1	0
2001	1	0
2002	4	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K042514, 1998–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 MNI? 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? (5)

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	Applicant	Decided	Recalls
*	K994217	Blackstone Spinal Fixation System Summary page 1 …is MNH - 888.3070 Spondylolisthesis Spinal Fixation Device System Substantially Equivalent Devices: BlackstoneTM Spinal Fixation System (K994217) BlackstoneTM SFS 4.5mm Multi-Axial Screws (K020674) BlackstoneTM SFS Modification to Multi-Axial Screws (K023498) Blackstone…	Blackstone Medical, Inc.	2000	—
*	K020674	Blackstone Spinal Fixation System 4.5MM Multi-Axial Screw Summary page 1 …ylolisthesis Spinal Fixation Device System Substantially Equivalent Devices: BlackstoneTM Spinal Fixation System (K994217) BlackstoneTM SFS 4.5mm Multi-Axial Screws (K020674) BlackstoneTM SFS Modification to Multi-Axial Screws (K023498) Blackstone TM SFS 4.5mm Mono-Axial Screws (K013558) BlackstoneT…	Blackstone Medical, Inc.	2002	—
*	K023498	Modification to Blackstone Spinal Fixation System Summary page 1 …valent Devices: BlackstoneTM Spinal Fixation System (K994217) BlackstoneTM SFS 4.5mm Multi-Axial Screws (K020674) BlackstoneTM SFS Modification to Multi-Axial Screws (K023498) Blackstone TM SFS 4.5mm Mono-Axial Screws (K013558) BlackstoneTM SFS Lateral Offset (K030581) Device Description: The…	Blackstone Medical, Inc.	2002	—
*	K013558	Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw Summary page 1 …(K994217) BlackstoneTM SFS 4.5mm Multi-Axial Screws (K020674) BlackstoneTM SFS Modification to Multi-Axial Screws (K023498) Blackstone TM SFS 4.5mm Mono-Axial Screws (K013558) BlackstoneTM SFS Lateral Offset (K030581) Device Description: The BlackstoneTM Modular Pedicle Screw System is comprise…	Blackstone Medical, Inc.	2002	—
*	K030581	Blackstone Spinal Fixation System Lateral Offset (System Modification) Summary page 1 …al Screws (K020674) BlackstoneTM SFS Modification to Multi-Axial Screws (K023498) Blackstone TM SFS 4.5mm Mono-Axial Screws (K013558) BlackstoneTM SFS Lateral Offset (K030581) Device Description: The BlackstoneTM Modular Pedicle Screw System is comprised of non-sterile, single use, titani…	Blackstone Medical, Inc.	2003	—

Also cleared against K994217: 9 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K111448	Icon (TM) Modular Pedicle Screw System	Orthofix, Inc.	2012	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 21, 2009	Not classified	Z-1655-2009	Finished device change control	Product marketed without an approved 510(k)
Dec 23, 2005	Not classified	Z-0716-06	Device Design	Pedicle Screw may disengage in post op period requiring intervention

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
None of the 12 ancestors has a recall.
Of its descendants, K111448 (Orthofix, Inc., 2012) has gone furthest, with 0 descendants of its own.
9 other devices also cite its predicate K994217.

How does its category compare?

All MNI devices

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

FDA decisions per year · MNI

1in 2017

2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007high 26 (2007) · low 0 (2011)2026

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

Adverse event reports per year · MNI

80in 2025

2007high 824 (2013) · low 80 (2025)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 Blackstone Modular Pedicle Screw System is intended for non-cervical use in the spine. The Blackstone Modular Pedicle Screw System, when used for pedicle screw fixation, is intended only for patients: a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; b) Who are receiving fusion using autogenous bone graft only; c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and d) Who are having the…

Read the full statement (304 words)

The Blackstone Modular Pedicle Screw System is intended for non-cervical use in the spine.

The Blackstone Modular Pedicle Screw System, when used for pedicle screw fixation, is intended only for patients:

a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;

b) Who are receiving fusion using autogenous bone graft only;

c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and

d) Who are having the device removed after the development of a solid fusion mass.

The Blackstone Modular Pedicle Screw System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:

a) Degenerative spondylolisthesis with objective evidence of neurologic impairment;

b) Fracture;

c) Dislocation;

d) Scoliosis;

e) Kyphosis;

f) Spinal tumor;

g) Failed previous fusion (pseudarthrosis).

The Blackstone Modular Pedicle Screw System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:

a) Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);

b) Spinal stenosis;

c) Spondylolisthesis;

d) Spinal deformities (i.e., scoliosis, kyphosis and/or lordosis);

e) Pseudoarthrosis;

f) Tumor;

g) Trauma (i.e., fracture or dislocation);

h) Failed previous fusion.

The Blackstone Modular Pedicle Screw System, when used for posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:

a) Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);

b) Spinal stenosis;

c) Spondylolisthesis;

d) Spinal deformities (i.e., scoliosis, kyphosis and/or lordosis);

e) Pseudoarthrosis;

f) Tumor;

g) Trauma (i.e., fracture or dislocation);

h) Failed previous fusion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042514 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042514: Modification to Blackstone Modular 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/K042514

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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