510(k) · Cleared
Recalled · Class II · 2013KRD1 Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinefrontier, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Nov 19, 2009 as substantially equivalent to K950099 (Buckman Co., Inc., 1997) and 2 other predicates after a 105-day review. Its family tree reaches back 3 generations to 1999. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 19, 2009
- Review
- 105 days
- Class
- Class II
- Product code
- MNI
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K990745 (1999). 13 ancestors in all, the oldest K901587 (1990). 6 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 2 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 1 generation backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- This deviceK092420 KRD1 Pedicle Screw SystemSpinefrontier, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK123164 Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc. · 2013 · Recalled
- Descendant · cites it directly · 1 of its ownK133153 Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK191655 MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK143377 PedFuse Pedicle Screw SystemSpinefrontier, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK113755 Savannah Technologies Spinal SystemSavannah Technologies, LLC · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc. · 2013 · cites it directly3descendants
- K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc. · 2014 · cites it directly1descendant
- K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd. · 2020 · 2 generations on0descendants
- K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc. · 2015 · cites it directly0descendants
- K113755Savannah Technologies Spinal SystemSavannah Technologies, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −2 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −1 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| 0 (this device) | K092420 | KRD1 Pedicle Screw System | Spinefrontier, Inc. | 2009 | — |
| +1 | K123164 | Spinefrontier Pedfuse Pedicle Screw System | Spinefrontier, Inc. | 2013 | 6 |
| +1 | K133153 | Spinefrontier Pedfuse Pedicle Screw System | Spinefrontier, Inc. | 2014 | — |
| +2 | K191655 | MEGAFIX® Pedicle Screw Spinal System | Seohancare Co., Ltd. | 2020 | — |
| +1 | K143377 | PedFuse Pedicle Screw System | Spinefrontier, Inc. | 2015 | — |
| +1 | K113755 | Savannah Technologies Spinal System | Savannah Technologies, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 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 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
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 |
|---|---|---|---|
| * | K950099 | Synergy (TM) TI Posterior Spinal SystemSummary page 1…(21 CFR 888.3070(b)(1)), Class 11 Product Code: MINH, MINI 3. Predicate Devices K950099 - Synergy Posterior Spinal System K992739 - Synthes USS Click-X Variable Axis System K0521 23 - Synthes P… | 1997 |
| * | K992739 | Click'xSummary page 1…70(b)(1)), Class 11 Product Code: MINH, MINI 3. Predicate Devices K950099 - Synergy Posterior Spinal System K992739 - Synthes USS Click-X Variable Axis System K0521 23 - Synthes Pangea System 4. Device Description… | 2000 |
| * | K052123 | Synthes Pangea SystemSummary page 1…NH, MINI 3. Predicate Devices K950099 - Synergy Posterior Spinal System K992739 - Synthes USS Click-X Variable Axis System K0521 23 - Synthes Pangea System 4. Device Description The KRD1jTM Pedicle Screw System consists of longitudinal rod… | 2005 |
What descends from it? (6)
5 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 14, 2013 | Class II | Z-1926-2013 | Device Design | Inserters have a set screw that fixes a collar to the inserter. The screw set can loosen and fall out of the inserter which allows the collar to slide off the proximal end of the inserter. When the collar is not in place the locking… |
| Dec 30, 2011 | Class II | Z-1737-2013 | Vendor change control | One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K123164 (Spinefrontier, Inc., 2013) has gone furthest, with 3 descendants of its own.
- 34 other devices also cite its predicate K950099.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 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 KRD1TM Pedicle Screw System is intended to provide immobilization and
stabilization of spinal segments in skeletally mature patients as an adjunct to
fusion in the treatment of the following acute instabilities or deformities of the
thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective
evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis,
spinal tumor, and failed previous fusion (Pseudoarthrosis).
In addition, the KRD1TM Pedicle Screw System is indicated for the treatment of
severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally
mature patients receiving fusion by autogenous bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092420 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092420: KRD1 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/K092420
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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