510(k) · Cleared
ClearedMahe Perfect Spine- Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mahe Medical GmbH · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 27, 2011 as substantially equivalent to K051971 (U&I Corp., 2005) and 2 other predicates after a 234-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Oct 27, 2011
- Review
- 234 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K990745 (1999). 5 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK110655 Mahe Perfect Spine- Pedicle Screw SystemMahe Medical GmbH · 2011
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) | K110655 | Mahe Perfect Spine- Pedicle Screw System | Mahe Medical GmbH | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 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 NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K051971 | Optima Spinal SystemSummary page 1…tebral body Fixation orthosis; Pedicle screw spinal system (21 CFR 888.3050, 888.3060, 888.3070) Product codes: NKB, KWP, KWQ MNH, MNI Class: III Predicate Devices: " K051971 - OPTIMATM Spinal System, U&l Corporation " K021564 - InCompass Spinal Fixation System, Spinal Concepts, Inc. " K052123 - Pangea… | 2005 |
| * | K021564 | Incompass Spinal Fixation SystemSummary page 1…system (21 CFR 888.3050, 888.3060, 888.3070) Product codes: NKB, KWP, KWQ MNH, MNI Class: III Predicate Devices: " K051971 - OPTIMATM Spinal System, U&l Corporation " K021564 - InCompass Spinal Fixation System, Spinal Concepts, Inc. " K052123 - Pangea TM System, Synthes Spine Description of the Device:… | 2002 |
| * | K052123 | Synthes Pangea SystemSummary page 1…P, KWQ MNH, MNI Class: III Predicate Devices: " K051971 - OPTIMATM Spinal System, U&l Corporation " K021564 - InCompass Spinal Fixation System, Spinal Concepts, Inc. " K052123 - Pangea TM System, Synthes Spine Description of the Device: The Mahe Perfect Spine - Pedicle Screw System consists of a variety… | 2005 |
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 12 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 17 other devices also cite its predicate K051971.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the Mahe Perfect Spine - 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 and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: (1) degenerative disc disease (defined as back…
Read the full statement (322 words)
When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the Mahe Perfect Spine - 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 and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) tumor, and (6) failed previous fusion (i.e. pseudarthrosis). In addition, when used as a pedicle screw system placed between L3 and S1, the Mahe Perfect Spine - Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) in skeletally mature patients receiving fusion with autologous bone graft and with removal of the device after solid fusion is established.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the Mahe Perfect Spine - Pedicle Screw System is intended for use in skeletally mature patients and pediatric patients for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) tumor resection, and/or (7) unsuccessful previous attempts at spinal fusion (pseudoarthrosis).
When intended for anterolateral fixation of the T6-L5 spine the Mahe Perfect Spine - Pedicle Screw System is indicated for: (1) degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) spondylolisthesis, (3) trauma (i.e. fracture or dislocation), (4) spinal stenosis, (5) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (6) tumor and (7) failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110655: Mahe Perfect Spine- 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/K110655
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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