510(k) · Cleared

Cleared

Blackstone Spinal Fixation System Posterior Hooks

K013885510(k) TraditionalCleared Feb 1, 200270-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

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

Cleared on Feb 1, 2002 as substantially equivalent to K981676 (Sofamor Danek USA,Inc., 1999) after a 70-day review. Its family tree reaches back 1 generation to 1999. 300 later devices descend from it.

Decided: Feb 1, 2002
Review: 70 days
Class: Class II
Product code: MNI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K981676 (1999). 300 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK981676 CD Horizon Spinal SystemSofamor Danek USA,Inc. · 1999
This deviceK013885 Blackstone Spinal Fixation System Posterior HooksBlackstone Medical, Inc. · 2002
Descendant · cites it directly · 298 of its ownK030581 Blackstone Spinal Fixation System Lateral Offset (System Modification)Blackstone Medical, Inc. · 2003
Descendant · cites it directly · 297 of its ownK030241 Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2003
Descendant · cites it directly · 296 of its ownK080407 Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc. · 2008 · Recalled
Descendant · 2 generations on · 277 of its ownK081684 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · Recalled
Descendant · 3 generations on · 209 of its ownK082797 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008

Showing 5 of 300 descendants. See all descendants

Descendants cleared per year

2003high 36 (2023) · low 0 (2005)2026

Most influential descendants

Showing 5 of 300 · See all

K030581Blackstone Spinal Fixation System Lateral Offset (System Modification)Blackstone Medical, Inc. · 2003 · cites it directly298descendants
K030241Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2003 · cites it directly297descendants
K080407Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc. · 2008 · cites it directly296descendants
K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · 2 generations on277descendants
K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · 3 generations on209descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K981676	CD Horizon Spinal System	Sofamor Danek USA,Inc.	1999	—
0 (this device)	K013885	Blackstone Spinal Fixation System Posterior Hooks	Blackstone Medical, Inc.	2002	—
+1	K030581	Blackstone Spinal Fixation System Lateral Offset (System Modification)	Blackstone Medical, Inc.	2003	—
+1	K030241	Modification to Blackstone Spinal Fixation System	Blackstone Medical, Inc.	2003	—
+1	K080407	Blackstone SFS Parallel Rod Connectors	Blackstone Medical, Inc.	2008	1
+2	K081684	Blackstone Pedicle Screw System	Blackstone Medical, Inc.	2008	3
+3	K082797	Blackstone Pedicle Screw System	Blackstone Medical, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	1	0
2008	3	0
2009	1	0
2010	4	0
2011	2	0
2012	5	0
2013	9	0
2014	5	0
2015	9	0
2016	12	0
2017	23	0
2018	16	0
2019	17	0
2020	23	0
2021	16	0
2022	23	0
2023	36	0
2024	33	0
2025	34	0
2026	26	0

FIG. 1 — Lineage of K013885, 1999–2026Source: 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? (1)

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
*	K981676	CD Horizon Spinal System Summary page 1 …ntervertebral Body Fixation Orthosis MNI 888.3070 — Pedicle Screw Spinal System KWP - 888.3050 - Spinal Interlaminal Fixation Orthosis Danek CD Horizon Spinal System (K981676) The Blackstone™ Spinal Fixation System Posterior Hooks are a titanium alloy; multiple component system comprised of a variety o…	Sofamor Danek USA,Inc.	1999	—

Also cleared against K981676: 17 other devices →

What descends from it? (300)

See all 300

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

Number	Device	Applicant	Decided	Descendants
K030581	Blackstone Spinal Fixation System Lateral Offset (System Modification)	Blackstone Medical, Inc.	2003	298
K030241	Modification to Blackstone Spinal Fixation System	Blackstone Medical, Inc.	2003	297
K080407	Blackstone SFS Parallel Rod Connectors	Blackstone Medical, Inc.	2008	296

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?

Its one ancestor has no recall.
Of its descendants, K030581 (Blackstone Medical, Inc., 2003) has gone furthest, with 298 descendants of its own.
17 other devices also cite its predicate K981676.

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?

Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation 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…

Read the full statement (291 words)

Blackstone Spinal Fixation System is intended for non-cervical use in the spine.

The Blackstone Spinal Fixation 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 Spinal Fixation 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; and

g) Failed previous fusion (pseudarthrosis).

The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle fixation, is intended for the following indications:

a) Degenerative disc disease (as 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) Pseudarthrosis;

f) Tumor;

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

h) Previous failed fusion.

The Blackstone Spinal Fixation System, when used for posterior non-pedicle fixation, is intended for the following indications:

a) Degenerative disc disease (as 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) Pseudarthrosis;

f) Tumor;

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

h) Previous failed fusion.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K013885 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013885: Blackstone Spinal Fixation System Posterior Hooks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013885

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026